Review Panel
Anesthesiology FDA 510(k) Clearances & Devices
- Cleared Devices
- 8,422
- Product Codes (page)
- 37
- Latest Decision
- 2026-09-25
Clearances · page 1 of 85
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K261372 | Profoject LOR Syringe | CMT Health PTE., Ltd. | CAZ | Class II | 2026-09-25 |
| K261262 | Altis Full Face Mask | Respironics, Inc. | BZD | Class II | 2026-09-25 |
| K260140 | Aevice Wheeze Detection Module | Aevice Health Pte. , Ltd. | PHZ | Class II | 2026-09-25 |
| K260949 | Disposable Belts for Polysomnography (CNSAC) | CNSAC Medshop GmbH | MNR | Class II | 2026-09-24 |
| K254289 | Portable Oxygen Concentrator (OX-1A-E, OX-1B) | Oxytek Medical Technology Co., Ltd. | CAW | Class II | 2026-09-23 |
| K254171 | Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210) | Shenzhen Mericonn Technology Co., Ltd. | CAF | Class II | 2026-09-18 |
| K260226 | ElintMAX Respiratory Monitor (ElintMAX Monitor A1) | Amptron Medical, Inc. | BZK | Class II | 2026-09-16 |
| K253063 | Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) | Vitaltec Corporation | BTO | Class II | 2026-09-11 |
| K251794 | Tenax® Laser Resistant Endotracheal Tube | Bryan Medical, Inc. | BTR | Class II | 2026-09-03 |
| K262268 | Optiflow Oxygen Kit (AA484J) | Fisher and Paykel Healthcare Limited | BTT | Class II | 2026-08-27 |
| K261360 | EasyCare Tx 2 | Resmed Corp | MOD | Class II | 2026-08-27 |
| K260604 | BiWaze Clear System | Abmrc, LLC | NHJ | Class II | 2026-08-24 |
| K260242 | CPETWise Platform | Medibyt , Ltd. | BTY | Class II | 2026-08-20 |
| K253807 | Valence InVent Xtend (CVG-4101-VXA) | Convergence Medical Sciences , Ltd. | MOD | Class II | 2026-08-20 |
| K260171 | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | BMC Medical Co., Ltd. | CAW | Class II | 2026-08-14 |
| K261499 | TrachFlush | Aw Technologies Aps | BSK | Class II | 2026-08-13 |
| K251641 | GF-310R Multigas Unit (GF-310R) | Nihon Kohden Corporation | CCK | Class II | 2026-08-12 |
| K254042 | WatchPAT SW | Itamar Medical , Ltd. | MNR | Class II | 2026-07-31 |
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) | Salter Labs | CCL | Class II | 2026-07-30 |
| K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | BZD | Class II | 2026-07-23 |
| K261011 | Sleep Apnea Feature (v2.0) | Samsung Electronics Co., Ltd. | QZW | Class II | 2026-07-20 |
| K260050 | WRAP System | Huneo, LLC | MNR | Class II | 2026-07-15 |
| K261633 | VisuBreath | Affirm Medical Technologies II, LLC | CCK | Class II | 2026-07-14 |
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | BSZ | Class II | 2026-06-25 |
| K253274 | BedDot (G1) | Intelligent Dots, LLC | BZQ | Class II | 2026-06-25 |
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | Microlife Corporation | BZH | Class II | 2026-06-23 |
| K253148 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | MNR | Class II | 2026-06-22 |
| K252066 | inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20) | Vincent Healthcare Products Limited | BZE | Class II | 2026-06-18 |
| DEN250025 | Syncron-E | Autonomous Healthcare, Inc. | QVC | Class II | 2026-06-18 |
| K252399 | Portable Oxygen Concentrator | Honsun (Nantong) Co., Ltd. | CAW | Class II | 2026-06-17 |
| K253001 | KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) | Hunan Ruijiong Biotech Co., Ltd. | NHJ | Class II | 2026-06-16 |
| K253437 | Spiro-VISTA | Spiro Robotics | BTR | Class II | 2026-06-12 |
| K251326 | Respiration Rate algorithm | Edwards Lifesciences, LLC | BZQ | Class II | 2026-06-11 |
| K253553 | Orion | Resmed Corp | BZD | Class II | 2026-06-04 |
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | CAF | Class II | 2026-06-02 |
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Tyto Care , Ltd. | PHZ | Class II | 2026-06-02 |
| K252965 | Oxygen Concentrator (OX-5A, OX-5C) | Oxytek Medical Technology Co., Ltd. | CAW | Class II | 2026-05-29 |
| K252802 | Peak Flow Meter (PF-10(BR-PEF231)) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | BZH | Class II | 2026-05-29 |
| K253119 | CoSense ETCO Monitor | Capnia, Inc. | CCJ | Class II | 2026-05-29 |
| K254104 | ResScan Essentials | Resmed Corp | BZD | Class II | 2026-05-27 |
| K254102 | Glucommander | Glytec, LLC | NDC | Class II | 2026-05-27 |
| K261098 | TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) | Senzime AB | KOI | Class II | 2026-05-22 |
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) | Drägerwerk AG Co. Kgaa | BSZ | Class II | 2026-05-21 |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. | BZD | Class II | 2026-05-21 |
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | CAH | Class II | 2026-05-15 |
| K260051 | CorVision® (91-205-Z0014) | CorVent® Medical, Inc. | MOD | Class II | 2026-05-12 |
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | CBK | Class II | 2026-05-07 |
| K260910 | EndoTool IV Cloud 1.0 | Glooko, Inc. | NDC | Class II | 2026-05-01 |
| K253030 | Capnostream35 Portable Respiratory Monitor (PM35MN) | Covidien, LLC | CCK | Class II | 2026-05-01 |
| K252849 | AffloVest® Mobile Airway Clearance Therapy | Tactile Medical | BYI | Class II | 2026-04-30 |
| K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | CAH | Class II | 2026-04-30 |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | BZD | Class II | 2026-04-29 |
| K252628 | CASSIE | Wesper, Inc. | MNR | Class II | 2026-04-27 |
| K252407 | OxyGo Portable Oxygen Concentrator (1400-7000) | Mv Life, LLC | CAW | Class II | 2026-04-23 |
| K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | BZD | Class II | 2026-04-17 |
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | CBK | Class II | 2026-04-14 |
| K254078 | HVT 2.0 | Vapotherm, Inc. | BTT | Class II | 2026-04-13 |
| K251889 | myAir | Resmed Corp | MNS | Class II | 2026-04-08 |
| K252182 | SV70 Ventilator (SV70) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MNT | Class II | 2026-04-06 |
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | Devilbiss Healthcare, LLC | CAW | Class II | 2026-03-26 |
| K253322 | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) | Medline Industries, LP | BZE | Class II | 2026-03-25 |
| K251950 | Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S) | Hangzhou Tappa Medical Technology Co., Ltd. | CBI | Class II | 2026-03-20 |
| K252078 | BreathePal Bilevel (GFM50-MD2201) | Compal Electronics, Inc. | MNS | Class II | 2026-03-17 |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | CBK | Class II | 2026-03-12 |
| K251584 | Medical Mesh Nebulizer (AirICU Max+) | AIRICU, Inc. | SFP | Class II | 2026-03-12 |
| K251777 | MESI mTABLET SPIRO | Mesi D.O.O. | BZG | Class II | 2026-03-02 |
| K251661 | Mariana Minerva; Mariana Nimbus | Resmed Pty , Ltd. | MNS | Class II | 2026-02-23 |
| K253096 | Chartis Precision Catheter | Pulmonx Corporation | CBI | Class II | 2026-02-13 |
| K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | BTT | Class II | 2026-01-16 |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | BZD | Class II | 2026-01-15 |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | BTT | Class II | 2026-01-14 |
| K253512 | MiniMed Go App | Medtronic Minimed | NDC | Class II | 2026-01-08 |
| K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | BZD | Class II | 2026-01-07 |
| K251165 | Saans (F4-01-00-000-000) | Innaccel Technologies Private Limited | SGR | Class II | 2026-01-06 |
| K251313 | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT | Covidien, LLC | JOH | Class II | 2025-12-29 |
| K251534 | Oxygen Concentrator (J10A) | Foshan Kycare Medical Equipment Co., Ltd. | CAW | Class II | 2025-12-29 |
| K251025 | Mon-a-Therm Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) | Covidien, LLC | BZT | Class II | 2025-12-29 |
| K253281 | UpDoc | Updoc, Inc. | NDC | Class II | 2025-12-23 |
| K252616 | Portable oxygen concentrator (JLO-190P) | Shenzhen Homed Medical Device Co., Ltd. | CAW | Class II | 2025-12-22 |
| K251764 | Oxygen Concentrator-P2-O5E | Qingdao Kingon Medical Science and Technology Co., Ltd. | CAW | Class II | 2025-12-22 |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | CBK | Class II | 2025-12-19 |
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | CAF | Class II | 2025-12-19 |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. | BTT | Class II | 2025-12-19 |
| K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | Shenzhen Harveymed Technology Co., Ltd. | CAW | Class II | 2025-12-16 |
| K251770 | SleepRes PAP System | Sleepres, Inc. | BZD | Class II | 2025-12-15 |
| K252497 | SANSA HSAT | Huxley Medical | MNR | Class II | 2025-12-10 |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | Devilbiss Healthcare, LLC | CAW | Class II | 2025-12-09 |
| K251657 | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | BZD | Class II | 2025-12-05 |
| K251631 | The BAG manual resuscitator and accessories | Laerdal Medical AS | BTM | Class II | 2025-11-24 |
| K251607 | Oxygen Concentrator (J5A) | Foshan Kycare Medical Equipment Co., Ltd. | CAW | Class II | 2025-11-21 |
| K250651 | OptiPAP Junior Flexi Tube US (OPTIPAPFUS); OptiPAP Junior Nasal Prongs XXS (OPTIPAPPXXS); OptiPAP Junior Nasal Prongs XS (OPTIPAPPXS); OptiPAP Junior Nasal Prongs S (OPTIPAPPS); OptiPAP Junior Nasal Prongs M (OPTIPAPPM); OptiPAP Junior Nasal Prongs L (OPTIPAPPL); OptiPAP Junior Nasal Prongs XL (OPTIPAPPXL); OptiPAP Junior Nasal Mask XXS (OPTIPAPMXXS); OptiPAP Junior Nasal Mask XS (OPTIPAPMXS); OptiPAP Junior Nasal Mask S (OPTIPAPMS); OptiPAP Junior Nasal Mask M (OPTIPAPMM); OptiPAP Jun | Fisher & Paykel Healthcare, Ltd. | SGR | Class II | 2025-11-19 |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | CAF | Class II | 2025-11-14 |
| K250882 | SANSA HSAT | Huxley Medical | MNR | Class II | 2025-10-29 |
| K250887 | Neuromuscular Transmission Monitor TOF3D (2510091) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | KOI | Class II | 2025-10-21 |
| K250173 | Shiley Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley Oral RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (115-XXOR) Shiley Nasal RAE Tracheal Tube with TaperGuard Cuff, Murphy Eye (119-XXNR) | Covidien, LLC | BTR | Class II | 2025-10-06 |
| K250860 | BreatheBand® (Model 1000) | Exemplar Medical, LLC | BYI | Class II | 2025-10-02 |
| K243833 | Portable oxygen concentrator (JAY-1000P) | Longfian Scitech Co., Ltd. | CAW | Class II | 2025-09-29 |
| K250093 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Linshom Medical, Inc. | BZQ | Class II | 2025-09-26 |
| K243785 | Shiley Oral/Nasal Tracheal Tube with TaperGuard Cuff Reinforced, Murphy Eye Shiley Tracheal Tube TaperGuard Cuff Reinforced with Stylet Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley Oral/Nasal Tracheal Tube Cuffless Reinforced | Covidien, LLC | BTR | Class II | 2025-09-25 |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | CAF | Class II | 2025-09-19 |
8,422 clearances in the Anesthesiology panel. Data: openFDA.