| WatchPAT SW (K254042) | Itamar Medical , Ltd. | 2026-07-31 |
| PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1) (K261389) | Salter Labs | 2026-07-30 |
| RXiBreeze PAP System (RXiBreeze 20C) (K253044) | Resvent Medical Technology Co., Ltd. | 2026-07-23 |
| Sleep Apnea Feature (v2.0) (K261011) | Samsung Electronics Co., Ltd. | 2026-07-20 |
| WRAP System (K260050) | Huneo, LLC | 2026-07-15 |
| VisuBreath (K261633) | Affirm Medical Technologies II, LLC | 2026-07-14 |
| A5 Anesthesia System (A5); A7 Anesthesia System (A7) (K253330) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-06-25 |
| BedDot (G1) (K253274) | Intelligent Dots, LLC | 2026-06-25 |
| Microlife Digital Peak Flow Meter, Model PF200B (PF200B) (K253180) | Microlife Corporation | 2026-06-23 |
| RX-1 Sleep (K253148) | Vivaquant, Inc. Dba Rhythm Express | 2026-06-22 |
| Syncron-E (DEN250025) | Autonomous Healthcare, Inc. | 2026-06-18 |
| inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20) (K252066) | Vincent Healthcare Products Limited | 2026-06-18 |
| Portable Oxygen Concentrator (K252399) | Honsun (Nantong) Co., Ltd. | 2026-06-17 |
| KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) (K253001) | Hunan Ruijiong Biotech Co., Ltd. | 2026-06-16 |
| Spiro-VISTA (K253437) | Spiro Robotics | 2026-06-12 |
| Respiration Rate algorithm (K251326) | Edwards Lifesciences, LLC | 2026-06-11 |
| Orion (K253553) | Resmed Corp | 2026-06-04 |
| FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) (K260270) | FindAir Sp. z o.o. | 2026-06-02 |
| Tyto Insights for Wheeze Detection (with PCCP) (K252844) | Tyto Care , Ltd. | 2026-06-02 |
| Peak Flow Meter (PF-10(BR-PEF231)) (K252802) | Shenzhen Bi-Rich Medical Devices Co., Ltd. | 2026-05-29 |
| CoSense ETCO Monitor (K253119) | Capnia, Inc. | 2026-05-29 |
| Oxygen Concentrator (OX-5A, OX-5C) (K252965) | Oxytek Medical Technology Co., Ltd. | 2026-05-29 |
| ResScan Essentials (K254104) | Resmed Corp | 2026-05-27 |
| Glucommander (K254102) | Glytec, LLC | 2026-05-27 |
| TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) (K261098) | Senzime AB | 2026-05-22 |
| Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask (K251920) | Dcstar, Inc. | 2026-05-21 |
| Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL) (K252746) | Drägerwerk AG Co. Kgaa | 2026-05-21 |
| Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled (K252643) | Teleflex Medical Sdn. Bhd. | 2026-05-15 |
| CorVision® (91-205-Z0014) (K260051) | CorVent® Medical, Inc. | 2026-05-12 |
| Evita (V800); Evita (V600) (K253647) | Draegerwerk AG & CO Kgaa | 2026-05-07 |
| Capnostream™35 Portable Respiratory Monitor (PM35MN) (K253030) | Covidien, LLC | 2026-05-01 |
| EndoTool IV Cloud 1.0 (K260910) | Glooko, Inc. | 2026-05-01 |
| Ambu® Virobac II® Exhalation Filter (K251583) | Ambu A/S | 2026-04-30 |
| AffloVest® Mobile Airway Clearance Therapy (K252849) | Tactile Medical | 2026-04-30 |
| F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (K253166) | BMC Medical Co., Ltd. | 2026-04-29 |
| CASSIE (K252628) | Wesper, Inc. | 2026-04-27 |
| OxyGo Portable Oxygen Concentrator (1400-7000) (K252407) | Mv Life, LLC | 2026-04-23 |
| MySleepDash (K252338) | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 |
| Inbentus Versatile (K252663) | Iconic Solutions by Murcia, SL | 2026-04-14 |
| HVT 2.0 (K254078) | Vapotherm, Inc. | 2026-04-13 |
| myAir (K251889) | Resmed Corp | 2026-04-08 |
| SV70 Ventilator (SV70) (K252182) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2026-04-06 |
| DeVilbiss 5 Liter Oxygen Concentrator (555) (K253549) | Devilbiss Healthcare, LLC | 2026-03-26 |
| 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) (K253322) | Medline Industries, LP | 2026-03-25 |
| 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) (K251950) | Hangzhou Tappa Medical Technology Co., Ltd. | 2026-03-20 |
| BreathePal Bilevel (GFM50-MD2201) (K252078) | Compal Electronics, Inc. | 2026-03-17 |
| Medical Mesh Nebulizer (AirICU Max+) (K251584) | AIRICU, Inc. | 2026-03-12 |
| VPAP Pediatric Face Mask (K251888) | Hsiner Co., Ltd. | 2026-03-12 |
| MESI mTABLET SPIRO (K251777) | Mesi D.O.O. | 2026-03-02 |
| Mariana Minerva; Mariana Nimbus (K251661) | Resmed Pty , Ltd. | 2026-02-23 |
| Chartis Precision Catheter (K253096) | Pulmonx Corporation | 2026-02-13 |
| FL-10000U Respiratory Humidifier (K251448) | Flexicare Medical Limited. | 2026-01-16 |
| Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (K251847) | Sleepnet Corporation | 2026-01-15 |
| Laboratorios Biogalenic Sterile Water for Inhalation, USP (K251419) | Laboratorios Biogalenic S.A. DE C.V. | 2026-01-14 |
| MiniMed Go App (K253512) | Medtronic Minimed | 2026-01-08 |
| DeltaWave Nasal Pillow System (K253939) | RemSleep Holdings, Inc. | 2026-01-07 |
| Saans (F4-01-00-000-000) (K251165) | Innaccel Technologies Private Limited | 2026-01-06 |
| Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (K251025) | Covidien, LLC | 2025-12-29 |
| 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 (K251313) | Covidien, LLC | 2025-12-29 |
| Oxygen Concentrator (J10A) (K251534) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-12-29 |
| UpDoc (K253281) | Updoc, Inc. | 2025-12-23 |
| Oxygen Concentrator-P2-O5E (K251764) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-12-22 |
| Portable oxygen concentrator (JLO-190P) (K252616) | Shenzhen Homed Medical Device Co., Ltd. | 2025-12-22 |
| eRapid with eTrack System (K251572) | Pari Respiratory Equipment, Inc. | 2025-12-19 |
| Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) (K253479) | Fisher & Paykel Healthcare, Ltd. | 2025-12-19 |
| Vivo 45 LS (K232365) | Oconnell Regulatory Consultants, Inc. | 2025-12-19 |
| V series portable oxygen concentrator (V5, V5C, V6, V6C) (K252268) | Shenzhen Harveymed Technology Co., Ltd. | 2025-12-16 |
| SleepRes PAP System (K251770) | Sleepres, Inc. | 2025-12-15 |
| SANSA HSAT (K252497) | Huxley Medical | 2025-12-10 |
| DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (K250805) | Devilbiss Healthcare, LLC | 2025-12-09 |
| Personalized Therapy Comfort Settings (PTCS) (K251657) | Resmed Corp | 2025-12-05 |
| The BAG manual resuscitator and accessories (K251631) | Laerdal Medical AS | 2025-11-24 |
| Oxygen Concentrator (J5A) (K251607) | Foshan Kycare Medical Equipment Co., Ltd. | 2025-11-21 |
| 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 (K250651) | Fisher & Paykel Healthcare, Ltd. | 2025-11-19 |
| Mesh Nebulizer (H6) (K251659) | Qingdao Future Medical Technology Co., Ltd. | 2025-11-14 |
| SANSA HSAT (K250882) | Huxley Medical | 2025-10-29 |
| Neuromuscular Transmission Monitor TOF3D (2510091) (K250887) | MIPM Mammendorfer Institut für Physik und Medizin GmbH | 2025-10-21 |
| 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) (K250173) | Covidien, LLC | 2025-10-06 |
| BreatheBand® (Model 1000) (K250860) | Exemplar Medical, LLC | 2025-10-02 |
| Portable oxygen concentrator (JAY-1000P) (K243833) | Longfian Scitech Co., Ltd. | 2025-09-29 |
| Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (K250093) | Linshom Medical, Inc. | 2025-09-26 |
| 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 (K243785) | Covidien, LLC | 2025-09-25 |
| Portable mesh nebulizer (JM821) (K244035) | Shenzhen Jermei Medical Device Technology Co., Ltd. | 2025-09-19 |
| F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full (K252173) | Fisher & Paykel Healthcare, Ltd. | 2025-09-10 |
| Enlight 2100 (TPL-E2103-0) (K250464) | Timpel S.A. | 2025-09-10 |
| WatchPAT400 (WP400) (K250460) | Itamar Medical , Ltd. | 2025-09-05 |
| Aerogen Pro-X1 Controller System (K251615) | Aerogen, Ltd. | 2025-09-02 |
| SV600, SV800 Ventilator (K243767) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2025-08-28 |
| Somfit D (K252383) | Compumedics Limited | 2025-08-28 |
| Medical Gas Analyzer (AG200) (K250148) | Prior Care Science Technology, Ltd. | 2025-08-28 |
| Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); Portable oxygen concentrator (W-R2); Portable oxygen concentrator (W-R2(Lite)) (K250625) | Nanjing Yinuoji Medical Technology Co., Ltd. | 2025-08-27 |
| InSee (K241152) | Tidal Medical Technologies, LLC | 2025-08-21 |
| Portable Oxygen Concentrator (JM-P50A) (K251130) | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 2025-08-21 |
| T1D1 (K252104) | Comerge AG | 2025-08-20 |
| Nerveblox (K250818) | Smart Alfa Teknoloji San. Ve Tic. A.S. | 2025-08-15 |
| AeroJet Ventilation Catheter (K243579) | Pipeline Medical Products, LLC | 2025-08-13 |
| CuffGuard (K243562) | Idmed | 2025-08-12 |
| OxyMinder Pro (10310) (K251245) | Bio-Med Device, Inc. | 2025-08-11 |
| LuMon(TM) System (K243765) | Sentec AG | 2025-08-07 |
| Respiree Cardio- Respiratory Monitor System (K250934) | Respiree Pte, Ltd. | 2025-08-05 |