FDA Product Code
FDA Product Code FPA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5440
510(k) Clearances — 1,175 records · page 1 of 12
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254123 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2026-09-11 | Abbreviated | PDF ↗ |
| K261530 | iiSure Infusion Set | Deka Research and Development | 2026-06-03 | Special | PDF ↗ |
| 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. | 2026-05-04 | Traditional | PDF ↗ |
| K251375 | PuraCath Firefly Needleless Connector IT (9005) | Puracath Medical, Inc. | 2026-02-12 | Traditional | PDF ↗ |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free Connector (NFC) [6426731]; nSyte Needle Free Connector (NFC) [6426727] | Np Medical | 2025-12-04 | Traditional | PDF ↗ |
| K250325 | BD Alaris Pump Infusion Set | Carefusion (Bd) | 2025-10-30 | Traditional | PDF ↗ |
| K251814 | EZ IV Administration Set | Epic Medical Pte. , Ltd. | 2025-08-29 | Traditional | PDF ↗ |
| K251854 | SteadiSet infusion set | Tandem Diabetes Care | 2025-08-06 | Abbreviated | PDF ↗ |
| K243841 | Sparta Infusion Set for Insulin | Deka Research and Development | 2025-08-01 | Traditional | PDF ↗ |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration Sets | B.Braun Medical, Inc. | 2025-07-24 | Traditional | PDF ↗ |
| K250616 | Clave Neutral-Displacement Needlefree Connectors | Icu Medical, Inc. | 2025-06-05 | Traditional | PDF ↗ |
| K242692 | SteadiSet Infusion Set | Capillary Biomedical, LLC | 2025-05-09 | Abbreviated | PDF ↗ |
| K242763 | JetCan® Pro Safety Huber Needle | Pfm Medical, Inc. | 2025-05-02 | Traditional | PDF ↗ |
| K243529 | Solution Administration Sets | Baxter Healthcare Corporation | 2025-03-14 | Traditional | PDF ↗ |
| K242339 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | 2025-02-28 | Traditional | PDF ↗ |
| K241058 | Lyka® PORT Needle Free Access Device (4170Y) | Quest Medical, Inc. | 2024-12-18 | Traditional | PDF ↗ |
| K234129 | Ecomed Disposable Administration Sets | Ecomed Solutions, LLC | 2024-09-20 | Traditional | PDF ↗ |
| K242126 | I.V. Administration Set | Bq Plus Medical Co., Ltd. | 2024-08-22 | Special | PDF ↗ |
| K232475 | Disposable infusion set with needle | Shandong Zhushi Pharmaceutical Group Co., Ltd. | 2024-05-10 | Traditional | PDF ↗ |
| K222766 | Disposable Extension Set | Shandong Ande Healthcare Apparatus Co., Ltd. | 2024-04-12 | Traditional | PDF ↗ |
| K232328 | Insignis Syringe Infusion System | Innovative Health Sciences, LLC | 2024-03-01 | Traditional | PDF ↗ |
| K231707 | ResQ Administration Set | Q For Plastic Industries | 2024-01-03 | Traditional | PDF ↗ |
| K230528 | Extension Set | Medcaptain Life Science Co., Ltd. | 2023-12-01 | Traditional | PDF ↗ |
| K222780 | LILY Extension Tube and Needleless Connector | Lily Medical Corporation | 2023-11-09 | Traditional | PDF ↗ |
| K230343 | ProSeal Closed System Administration Set | Epic Medical Pte. , Ltd. | 2023-11-03 | Traditional | PDF ↗ |
| K221327 | BD Alaris Pump Infusion Sets | Care Fusion | 2023-07-21 | Traditional | PDF ↗ |
| K221411 | Surflo Winged Infusion Set | Terumo Medical Products (Hangzhou) Co., Ltd. | 2023-06-23 | Traditional | PDF ↗ |
| K221121 | Volumat Polyethylene I.V. Administration Set | Fresenius Kabi | 2023-06-16 | Traditional | PDF ↗ |
| K230992 | DJF Intravascular Administration Set | Yangzhou Wei DE LI Trade Co., Ltd. | 2023-06-09 | Traditional | PDF ↗ |
| K220301 | Volumat Line | Fresenius Kabi | 2023-06-02 | Traditional | PDF ↗ |
| K223645 | I.V. Administration Set, I.V. Extension Set | Bq Plus Medical Co., Ltd. | 2023-05-18 | Traditional | PDF ↗ |
| K223101 | BD Secondary Infusion Set | Care Fusion | 2023-05-12 | Traditional | PDF ↗ |
| K220288 | NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector | Np Medical, Inc. | 2023-04-19 | Traditional | PDF ↗ |
| K220312 | Polyfusion IV Administration Sets | Poly Medicure Limited | 2023-04-12 | Traditional | PDF ↗ |
| K223088 | BD SmartSite Needle-Free Connector | Care Fusion | 2023-04-07 | Traditional | PDF ↗ |
| K222889 | FlowArt® Needle-Free Split Septum Valve | Asset Medikal Tasarim San Tic As. | 2023-01-20 | Traditional | PDF ↗ |
| K221075 | Infusion Sets for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 | Traditional | PDF ↗ |
| K221078 | Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 | Traditional | PDF ↗ |
| K221069 | Infusion Sets for Single Use with Needles | Sichuan Prius Biotechnology Co., Ltd. | 2022-11-21 | Traditional | PDF ↗ |
| K221518 | NP Medical nCompass Extension Set with Stabilizing Base | Np Medical | 2022-11-03 | Traditional | PDF ↗ |
| K220267 | AMSafe NeuFlo Needleless Connector | Amsino International, Inc. | 2022-10-07 | Traditional | PDF ↗ |
| K212262 | PCA Syringe Sets | Baxter Healthcare Corporation | 2022-10-03 | Traditional | PDF ↗ |
| K221473 | Flowart | Asset Medikal Tasarim As. | 2022-09-26 | Traditional | PDF ↗ |
| K221481 | NeutrArt | Asset Medikal Tasarim As. | 2022-09-23 | Traditional | PDF ↗ |
| K213846 | Q2 Blood Administration Sets | Quest Medical, Inc. | 2022-06-05 | Traditional | PDF ↗ |
| K213588 | Q2 IV Administration Sets | Quest Medical, Inc. | 2022-06-02 | Traditional | PDF ↗ |
| K213004 | Needle Free Connector | Medcaptain Life Science Co., Ltd. | 2022-05-10 | Traditional | PDF ↗ |
| K202437 | Infusion Sets for Single Use | Jiangsu Suyun Medical Materials Co., Ltd. | 2022-03-25 | Traditional | PDF ↗ |
| K213778 | IV Administration Set | B.Braun Medical, Inc. | 2022-03-03 | Traditional | PDF ↗ |
| K212842 | Microvolume Luer Access Device | B.Braun Medical, Inc. | 2022-01-18 | Traditional | PDF ↗ |
| K213089 | Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector | Ivenix, Inc. | 2021-11-10 | Special | PDF ↗ |
| K203609 | Intravascular Administration Sets | Baxter Healthcare Corporation | 2021-09-30 | Traditional | PDF ↗ |
| K202618 | IV Administration Sets | B.Braun Medical, Inc. | 2021-09-24 | Traditional | PDF ↗ |
| K210381 | I.V. Administration Set | Bq Plus Medical Co., Ltd. | 2021-08-14 | Traditional | PDF ↗ |
| K202279 | Insignis Subcutaneous Needle Sets | Innovative Health Sciences, LLC | 2021-08-13 | Traditional | PDF ↗ |
| K203796 | Firefly Needleless Connector | Puracath Medical, Inc. | 2021-07-30 | Traditional | PDF ↗ |
| K210544 | Medtronic Extended infusion set | Unomedical A/S | 2021-07-16 | Traditional | PDF ↗ |
| K210430 | Intravascular Extension Set | Baxter Healthcare Corporation | 2021-06-18 | Traditional | PDF ↗ |
| K210217 | Needleless Connector | Jiangsu Caina Medical Co.,Ltd | 2021-05-17 | Traditional | PDF ↗ |
| K201626 | Safety Subcutaneous Infusion Set | Epic Medical Pte. , Ltd. | 2021-03-24 | Traditional | PDF ↗ |
| K200439 | Velano ExT Extension Set | Velano Vascular | 2021-02-23 | Traditional | PDF ↗ |
| K202672 | Precision Delivery Infusion Set | Quest Medical, Inc. | 2021-01-21 | Traditional | PDF ↗ |
| K201872 | NeutrArt | Asset Medikal Tasarim As. | 2021-01-05 | Traditional | PDF ↗ |
| K200425 | Female Luer Lock Cap | Medsafety Solutions, LLC | 2020-10-29 | Traditional | PDF ↗ |
| K193088 | MaxZero Extension Sets with Needle-Free Connector(s) | Carefusion, Inc. | 2020-10-23 | Traditional | PDF ↗ |
| K200661 | Steripath Micro Blood Collection System | Magnolia Medical Technologies, Inc. | 2020-10-08 | Special | PDF ↗ |
| K192375 | Intellifuse Administration and Intellifuse Blood Administration Sets | Smiths Medical Asd, Inc. | 2020-09-18 | Traditional | PDF ↗ |
| K191640 | TK Intravascular Administration Set | Anhui Tiankang Medical Technology Co., Ltd. | 2020-08-26 | Traditional | PDF ↗ |
| K192681 | Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2020-07-28 | Traditional | PDF ↗ |
| K192366 | Intravascular Extension Sets and Accessories | Baxter Healthcare Corporation | 2020-07-20 | Traditional | PDF ↗ |
| K191362 | LifeFlow Blood System | 410 Medical, Inc. | 2020-05-20 | Traditional | PDF ↗ |
| K191658 | IV Sets not made with PVC | B.Braun Medical, Inc. | 2020-03-19 | Traditional | PDF ↗ |
| K190806 | Flowart | Asset Medikal Tasarim As. | 2020-02-20 | Traditional | PDF ↗ |
| K192647 | neria guard Infusion Set | Unomedical A/S | 2019-12-13 | Traditional | PDF ↗ |
| K180739 | Clearlink System Solution Set | Baxter Healthcare Corporation | 2019-05-28 | Traditional | PDF ↗ |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) | Kawasumi Laboratories, Inc. | 2019-05-02 | Special | PDF ↗ |
| K180843 | HIgH-Flo Super26 Subcutaneous Needle Sets | Repro-Med Systems, Inc. Dba Rms Medical Products | 2019-04-04 | Traditional | PDF ↗ |
| K182897 | Velano Vascular Q2 Extension Set | Velano Vascular | 2019-03-26 | Traditional | PDF ↗ |
| K181870 | Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use | Wuhan W.E.O Science & Technology Development Co., Ltd. | 2019-02-26 | Traditional | PDF ↗ |
| K182545 | Tamper Evident Cap with Male Luer Lock | International Medical Industries, Inc. | 2019-01-11 | Traditional | PDF ↗ |
| K181718 | BD FlowSmart Set/MiniMed Pro-Set | Becton, Dickinson and Company | 2018-10-18 | Traditional | PDF ↗ |
| K173665 | AMSafe Sure-Lok Needle-Free Connector | Amsino International, Inc. | 2018-09-05 | Traditional | PDF ↗ |
| K173361 | IV Administration Set | B.Braun Medical, Inc. | 2018-06-26 | Traditional | PDF ↗ |
| K173879 | MiniMed Mio Advance infusion set | Unomedical A/S | 2018-03-05 | Traditional | PDF ↗ |
| K170595 | IV Administration Sets | B.Braun Medical, Inc. | 2017-11-07 | Traditional | PDF ↗ |
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set | Unomedical A/S | 2017-11-01 | Traditional | PDF ↗ |
| K172544 | IV Fat Emulsion Administration Sets | Baxter Healthcare Corporation | 2017-09-22 | Special | PDF ↗ |
| K170002 | Medline Blood Collection Set | Medline Industries, Inc. | 2017-09-19 | Traditional | PDF ↗ |
| K171117 | Carefusion NeutraClear Needle-free connector (EL-NC1000) | Cair Lgl | 2017-09-01 | Traditional | PDF ↗ |
| K171118 | Carefusion NeutraClear multi-fuse Extension Set with needle-free connector(s) | Cair Lgl | 2017-08-15 | Traditional | PDF ↗ |
| K171132 | Carefusion NeutraClear Needle-free connector | Cair Lgl | 2017-07-31 | Special | PDF ↗ |
| K162951 | TUBETECH IV Administration Set | Douglas Medical Products, Inc. | 2017-07-28 | Traditional | PDF ↗ |
| K171957 | MaxZero Extension Sets with Needless Connector | Carefusion 303, Inc. | 2017-07-19 | Traditional | PDF ↗ |
| K161808 | Solution Set with 1.2 Micron Air Eliminating Filter | Baxter Healthcare Corporation | 2017-06-21 | Traditional | PDF ↗ |
| K162826 | Encore Neutral | Rymed Technologies, LLC | 2017-06-15 | Traditional | PDF ↗ |
| K171101 | Closed Male Luer | Yukon Medical | 2017-06-02 | Traditional | PDF ↗ |
| K162601 | Infusion Set for Single Use | Shinva Ande Healthcare Apparatus Co., Ltd. | 2017-05-31 | Traditional | PDF ↗ |
| K163160 | Sterile Single-use Infusion Set | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-04-20 | Traditional | PDF ↗ |
| K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc. | 2017-03-08 | Traditional | PDF ↗ |
| K161898 | Burette-type Infusion Sets for Single Use, Disposable Infusion Sets with Precision Filters, Disposable Infusion Set | Beijing Fert Technology Co., Ltd. | 2017-03-08 | Traditional | PDF ↗ |
Product code FPA · Class II · General Hospital. Data: openFDA.