Review Panel
General Hospital FDA 510(k) Clearances & Devices
- Cleared Devices
- 15,723
- Product Codes (page)
- 43
- Latest Decision
- 2026-10-01
Clearances · page 1 of 158
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K262208 | Non-sterile, Powder Free Nitrile Examination Aloe Vera Green Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid;Non-sterile, Powder Free Nitrile Examination Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Blue;Non-sterile, Powder Free Nitrile Examination Gloves - Pink | Yty Industry (Manjung) Sdn Bhd | LZA | Class I | 2026-10-01 |
| K261992 | 3M Attest Steam Chemical Integrator (1243A, 1243B, 1243RE, 1243RES) | Solventum US, LLC | JOJ | Class II | 2026-09-25 |
| K262532 | NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61) | ICU Medical | LGZ | Class II | 2026-09-18 |
| K254095 | 25G Huber Needle | Martech Medical Products | PTI | Class II | 2026-09-18 |
| K261266 | MOWANA Auto Duo | PENTAMASTER MEDIQ SDN BHD | FMI | Class II | 2026-09-17 |
| K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | FPA | Class II | 2026-09-11 |
| K262542 | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | Top Glove Sdn. Bhd. | LZA | Class I | 2026-09-09 |
| K261793 | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | Maxter Healthcare, Inc. | LZA | Class I | 2026-09-09 |
| K260312 | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | Gmp Medicare Sdn. Bhd. | LZA | Class I | 2026-09-08 |
| K253988 | LiteSet Trays | Nobel Biocare AB | KCT | Class II | 2026-09-08 |
| K261935 | Surgical and Prosthetic Trays | Dentsply Sirona, Inc. | KCT | Class II | 2026-09-04 |
| K262153 | Pivot Insulin Delivery System | Modular Medical, Inc. | LZG | Class II | 2026-09-02 |
| K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | Cardinalhealth | LZA | Class I | 2026-09-02 |
| K260432 | Ruby Intravascular Catheter | Venocare, Inc. | FOZ | Class II | 2026-09-02 |
| K261403 | Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter | Global Life Sciences Solutions USA, LLC | FPB | Class II | 2026-08-31 |
| K262581 | GraftGun Universal Graft Delivery System (GDS®) | SurGenTec, LLC | FMF | Class II | 2026-08-26 |
| K261719 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2026-08-25 |
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | Sol-Millennium Medical, Inc. | FMF | Class II | 2026-08-25 |
| DEN250046 | Aletta® Autonomous Robotic Phlebotomy Device (ARPD) (Gen1 US) | Vitestro | SIW | Class II | 2026-08-19 |
| K260794 | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | Kossan International Sdn Bhd | LZA | Class I | 2026-08-18 |
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Jiangsu Enjosim Medical Technology Co., Ltd. | FMF | Class II | 2026-08-14 |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII) | Hh Global Technology, Inc. | FMI | Class II | 2026-08-10 |
| K260165 | Unimpregnated Central Venous Catheter | Spectrum Vascular | FOZ | Class II | 2026-08-10 |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R, NR-S2038R, NR-S2051R, NR-S2116R, NR-S2125R, NR-S2138R, NR-S2151R, NR-S2216R, NR-S2225R, NR-S2238R, NR-S2251R, NR-S2316R, NR-S2325R, NR-S2338R, NR-S2351R, NR-S2516R, NR-S2525R, NR-S2538R, NR-S2551R, NR-S2516T, NR-S2525T, NR-S2538T, NR-S2551T) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | FMI | Class II | 2026-08-07 |
| K260845 | Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. | MMK | Class II | 2026-08-05 |
| K253760 | OMNI Ultra Surgical System (1-110) | Sight Sciences, Inc. | MRH | Class II | 2026-08-04 |
| K261829 | Profoject Dual-Safety Pen Needles | CMT Health PTE., Ltd. | FMI | Class II | 2026-07-29 |
| K260326 | Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) | Datex-Ohmeda, Inc. | FMZ | Class II | 2026-07-28 |
| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) Injection | Deka R&D Corp | FRN | Class II | 2026-07-24 |
| K262014 | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves | O&M Halyard, Inc. | LZA | Class I | 2026-07-21 |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2026-07-20 |
| K260739 | Profoject Pen Needles (Model A; Model B) | CMT Health PTE., Ltd. | FMI | Class II | 2026-07-15 |
| K260208 | Ultra-Fine SAFETY Insulin Syringe | embecta Medical II, LLC | FMF | Class II | 2026-07-13 |
| K261041 | ClearSafe Closed System | MedSource Labs, LLC | FOZ | Class II | 2026-07-10 |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter | MedSource Labs, LLC | FOZ | Class II | 2026-07-09 |
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* Technology | O&M Halyard, Inc. | FRG | Class II | 2026-07-02 |
| K253527 | Tri-Staple 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT) | Covidien, LLC | GAG | Class II | 2026-07-01 |
| K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | FLE | Class II | 2026-06-24 |
| K252117 | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution | Sw Technologies, Inc. | LZA | Class I | 2026-06-24 |
| K253824 | Powder Free Nitrile Examination Gloves Non-Sterile Black | Kanglongda Vietnam Protection Technology Company Limited | LZA | Class I | 2026-06-18 |
| K253187 | SteriBest® Sterilization Tray System | Mastel Surgical | KCT | Class II | 2026-06-18 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | FMF | Class II | 2026-06-18 |
| K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | QVB | Class II | 2026-06-18 |
| K260916 | FLEXI-PORT Power Injectable Implantable Port | Portal Access, Inc. | LJT | Class II | 2026-06-17 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | Hartalega NGC Sdn. Bhd. | LZA | Class I | 2026-06-17 |
| K260514 | Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle | CMT Health PTE., Ltd. | FMF | Class II | 2026-06-12 |
| K252987 | ADRx Admixture Device | Epic Medical Pte. , Ltd. | LHI | Class II | 2026-06-12 |
| K253688 | MEDRAD® Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | PQH | Class II | 2026-06-12 |
| K260855 | Profoject Safety Pen Needles | CMT Health PTE., Ltd. | FMI | Class II | 2026-06-10 |
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | LHI | Class II | 2026-06-05 |
| K253162 | Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG) | Unimed Medical Supplies, Inc. | FLL | Class II | 2026-06-05 |
| K261530 | iiSure Infusion Set | Deka Research and Development | FPA | Class II | 2026-06-03 |
| K260806 | Nitrile Disposable Examination Gloves | Vista Industries,, LLC | LZA | Class I | 2026-06-03 |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801) | Institut Straumann AG | KCT | Class II | 2026-06-03 |
| K252854 | SteriTite Container System with MediTray Products | Case Medical, Inc. | KCT | Class II | 2026-06-03 |
| K260703 | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl;Powder Free Black Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl | S&S Glove Corporation | LZA | Class I | 2026-06-03 |
| K252823 | Dukal Crepe Paper Sterilization Wrap | Dukal, LLC | FRG | Class II | 2026-05-28 |
| K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong | Taizhou Huangyan Guanhong Plastic Steel Products Factory | MMK | Class II | 2026-05-22 |
| K253112 | Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe) | Hlb Lifescience Co., Ltd. | FMF | Class II | 2026-05-21 |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization Wrap | O&M Halyard, Inc. | FRG | Class II | 2026-05-18 |
| K253235 | Introcan Safety® Deep Access XL IV Catheter | B.Braun Medical, Inc. | FOZ | Class II | 2026-05-15 |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) | Amsino International, Inc. | FPA | Class II | 2026-05-04 |
| DEN240075 | Prolystica Pass Thru Disinfectant Wipes | Steris | SHM | Class II | 2026-05-01 |
| K250680 | Bayesian Health Sepsis Flagging Device | Bayesian Health, Inc. | SAK | Class II | 2026-04-30 |
| K252471 | Paptizer 360 | LiViliti Health Products Corporation | QXQ | Class II | 2026-04-29 |
| K260988 | °M Warmer System with °M Station | Mequ A/S | LGZ | Class II | 2026-04-24 |
| K250234 | SMARTeZ Elastomeric Infusion Pump (RS series) | Epic Medical Pte. , Ltd. | MEB | Class II | 2026-04-24 |
| K252306 | Verrix EVA STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA Auto-Reader (Model: 1100) | Steritec Products | QVB | Class II | 2026-04-22 |
| K253558 | Luminoah FLOW Enteral Nutrition System | Luminoah | LZH | Class II | 2026-04-20 |
| K260929 | Neonav ECG Tip Location System | Navi Medical Technologies | LJS | Class II | 2026-04-17 |
| K252279 | Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) | Chirana T.Injecta,A.S. | FMF | Class II | 2026-04-17 |
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | FMI | Class II | 2026-04-16 |
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104) | Advanced Sterilization Products, Inc. | MLR | Class II | 2026-04-15 |
| K252757 | CeQur Simplicity On-Demand Insulin Delivery System | Cequr SA | OPP | Class II | 2026-04-10 |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 | STERIS Corporation | MED | Class II | 2026-04-08 |
| K260766 | Celerity 5 HP Biological Indicator (LCB052) | STERIS Corporation | FRC | Class II | 2026-04-08 |
| K253534 | Pivot Insulin Delivery System | Modular Medical | LZG | Class II | 2026-04-08 |
| K260860 | Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) | Basic Medical Technology, Inc. | LYZ | Class I | 2026-04-07 |
| K252130 | LifeShield Infusion Safety Software Suite | Icu Medical, Inc. | PHC | Class II | 2026-04-02 |
| K252137 | BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | FOZ | Class II | 2026-04-02 |
| K252079 | Disposable Infusion Bag for Parenteral Nutrition | Beijing L&Z Medical Technology Development Co., Ltd. | KPE | Class II | 2026-04-02 |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm) | Poly Medicure Limited | FOZ | Class II | 2026-04-01 |
| K252006 | OTTO Disinfecting Cap | Icu Medical, Inc. | QBP | Class II | 2026-03-27 |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle; Easydrip Plus Pro Pen Needle | Sandstone Medical (Suzhou), Inc. | FMI | Class II | 2026-03-25 |
| K253047 | PRESSONE | Nipro Medical Corporation | FMI | Class II | 2026-03-24 |
| K251980 | ClaveQS Bag | Icu Medical, Inc. | KPE | Class II | 2026-03-20 |
| K253622 | Safety Pen Needle | Ningbo Medsun Medical Co., Ltd. | FMI | Class II | 2026-03-18 |
| K252282 | SurgiCount+ System | Stryker Instruments | PBZ | Class II | 2026-03-16 |
| K253267 | CORIS System | Nanosonics Limited | SEW | Class II | 2026-03-05 |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | DePuy Mitek, Inc. | KCT | Class II | 2026-02-26 |
| K260254 | Enbio PRO | Enbio Group AG | FLE | Class II | 2026-02-26 |
| K253996 | BD Surgiphor Antimicrobial Irrigation System (910110) | Becton, Dickinson and Company (BD) | FQH | Class II | 2026-02-25 |
| K253068 | Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe | CMT Health PTE., Ltd. | FMF | Class II | 2026-02-23 |
| K260181 | LF Process Indicator Tape for Steam Sterilization | Intertape Polymer Group | JOJ | Class II | 2026-02-20 |
| K253445 | BD Surgiphor 1000 mL Antimicrobial Irrigation System (910120) | Bd | FQH | Class II | 2026-02-20 |
| K252814 | Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe | CMT Health PTE., Ltd. | QNQ | Class II | 2026-02-19 |
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) | Methyl Co., Ltd. | MEG | Class II | 2026-02-18 |
| K251619 | Babyleo TN500 | Drägerwerk AG & Co. KGaA | FMZ | Class II | 2026-02-13 |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | FPA | Class II | 2026-02-12 |
| K251592 | SteriHub Disinfecting Device and Protective Cover | 1World Vista Medical | QBP | Class II | 2026-02-11 |
15,723 clearances in the General Hospital panel. Data: openFDA.