| Heated Breathing Tube (K243244) | Guangdong Eda Technology Co., Ltd. | 2025-07-25 |
| Respond OC Conserving Regulator (130-0800) (K250322) | Responsive Respiratory | 2025-07-24 |
| F&P Optiflow Air/Oxygen Flow Source (K243917) | Fisher & Paykel Healthcare, Ltd. | 2025-07-14 |
| Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration) (K251352) | Codonics.Incorporated | 2025-07-11 |
| FreeStyle Comfort (AS200 / FreeStyle Comfort) (K250671) | Caire, Inc. | 2025-07-11 |
| Onera STS 2 (ONERA STS 2) (K243220) | Onera B.V. | 2025-07-03 |
| Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) (K243468) | Joytech Healthcare Co. , Ltd. | 2025-07-02 |
| Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small (K250312) | Medline Industries, LP | 2025-07-02 |
| SonoMSK (K243690) | PAJUNK GmbH Medizintechnologie | 2025-07-01 |
| HeroTracker Sense (K250022) | Voluntis | 2025-06-30 |
| SonoPlex STIM; SonoPlex II (K243682) | PAJUNK GmbH Medizintechnologie | 2025-06-27 |
| RTMsense Respiratory Monitoring System (K243183) | Rtm Vital Signs, LLC | 2025-06-27 |
| SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (K250774) | PAJUNK GmbH Medizintechnologie | 2025-06-25 |
| Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) (K251611) | Fisher & Paykel Healthcare, Ltd. | 2025-06-25 |
| WiTOF (K243339) | Idmed | 2025-06-23 |
| AdheResp Smart Breath-actuated Mesh Nebulizer (K250583) | Hcmed Innovations Co., Ltd. | 2025-06-20 |
| Happy Health Home Sleep Test (K242224) | Happy Health, Inc. | 2025-06-18 |
| F&P Nova Nasal Mask (K243583) | Fisher & Paykel Healthcare Limited | 2025-06-18 |
| Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS) (K251499) | William Cook Europe Aps | 2025-06-11 |
| 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm (K242921) | Vitaltec Corporation | 2025-06-10 |
| TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1) (K243956) | Nihon Kohden Corporation | 2025-06-10 |
| Portable Oxygen Concentrator (Spirit-3) (K242736) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | 2025-06-05 |
| 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line (K251216) | Barbaras Development, Inc. | 2025-06-04 |
| myAir (K250624) | Resmed Corp | 2025-05-28 |
| WiZARD 520 Full Face Mask (K243023) | Wellell, Inc. | 2025-05-23 |
| EveryWare (K242485) | Breas Medical AB | 2025-05-20 |
| ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.0) (038-995-070U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 7.5) (038-995-075U); ProVu Single Use Video Stylet with Reinforced ET Tube (Size 8.0) (038-995-080U) (K250243) | Flexicare Medical Limited. | 2025-05-20 |
| AirFit F20 Mask System; AirFit F20 NM Mask System (K242547) | Resmed Pty , Ltd. | 2025-05-19 |
| Clearo (K242438) | Breas Medical AB | 2025-05-16 |
| HFT750U (K242931) | Mekics Co., Ltd. | 2025-05-15 |
| AVEA disposable expiratory filter/water trap (11790) (K251133) | Telesair, Inc. | 2025-05-08 |
| AllNEB (K242354) | Enchant Tek Co. , Ltd. | 2025-04-29 |
| LMA Fastrach ETT SU (K242495) | Teleflex Medical | 2025-04-29 |
| butterflyBVM (K243861) | Compact Medical, Inc. | 2025-04-25 |
| Smart Check O2 (MA0236) (K250002) | Life Spark Medical, LLC | 2025-04-24 |
| FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) (K243966) | Faceheart Corp. | 2025-04-09 |
| Tyto Insights for Rhonchi Detection (K243567) | Tyto Care , Ltd. | 2025-04-07 |
| Philips VSC-MEDlib (K242001) | Philips Medical Systems Nederland B.V. | 2025-04-04 |
| VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (K242769) | Draegerwerk AG & CO Kgaa | 2025-04-04 |
| Makani Science™ Respiration Monitoring System (K233953) | Makani Science, Inc. | 2025-03-28 |
| SonoTAP and SonoTAP II (K243525) | PAJUNK GmbH Medizintechnologie | 2025-03-24 |
| AcuPebble Ox (200) (K243092) | Acurable Limited | 2025-03-19 |
| CuffTrek (K242642) | Shanghai Longmann Tech Co., Ltd. | 2025-03-07 |
| Portable Oxygen Concentrator (P2-TOC) (K242718) | Qingdao Kingon Medical Science and Technology Co., Ltd. | 2025-02-28 |
| Airmod (K242798) | Heroic Faith International , Ltd. | 2025-02-28 |
| EDEN ControlCath (K241410) | Jmt Co., Ltd. | 2025-02-13 |
| Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch Endotracheal Tubes (Safety Clear Pediatric) (K241451) | Teleflex Incorporated | 2025-02-11 |
| TipTraQ (TTQ001) (K243268) | Pranaq Pte. , Ltd. | 2025-02-03 |
| Laboratorios Biogalenic Sterile Water for Inhalation, USP (K242717) | Laboratorios Biogalenic S.A. DE C.V. | 2025-01-30 |
| SANSA HSAT (K244027) | Huxley Medical | 2025-01-28 |
| ULSPIRA TS™ Nitric Oxide Therapy System (K242374) | Airgas Therapeutics, LLC | 2025-01-17 |
| AeroChamber2go Anti-Static Valved Holding Chamber (K242667) | Trudell Medical International | 2025-01-15 |
| Respiration Data Management Software (PAP Link PC) (K242935) | BMC Medical Co., Ltd. | 2025-01-15 |
| Vivo 45 LS (K233452) | Breas Medical AB | 2025-01-13 |
| DormoTech NLab (K242290) | Dormotech Medical, Ltd. | 2025-01-08 |
| EVOLVE Nitric Oxide Delivery System (K242578) | Mallinckrodt Manufacturing, LLC | 2025-01-03 |
| Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) (K243225) | Genadyne Biotechnologies, Inc. | 2024-12-31 |
| Peak Flow Meter (K241338) | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-31 |
| AF531 Oro-Nasal SE Face Mask (K243394) | Respironics, Inc. | 2024-12-30 |
| SIMEOX 200 Airway Clearance Device (K241091) | Inogen, Inc. | 2024-12-23 |
| LibAirty Airway Clearance System (K242063) | Synchrony Medical , Ltd. | 2024-12-19 |
| Hudson RCI Comfort Flo® CubCannula™ (K241778) | Medline Industries, LP | 2024-12-19 |
| Bluebird Single-Use Respiratory Effort Belt (K242424) | Cadwell Industries, Inc. | 2024-12-18 |
| Respiratory Muscle Trainer (K240959) | Chongqing Moffy Innovation Technology Co., Ltd. | 2024-12-18 |
| AIM (N/A) (K240937) | Inventeur, LLC | 2024-12-16 |
| Vivo 3 (K240779) | Breas Medical AB | 2024-12-13 |
| Vivo 1, Vivo 2 (K240778) | Breas Medical AB | 2024-12-13 |
| 731 Series Ventilator (K233486) | ZOLL Medical Corporation | 2024-12-13 |
| EndoTool IV (3.1) (K241088) | Monarch Medical Technologies | 2024-12-11 |
| PowerCube+ Series (PowerCube Body+); PowerCube+ Series (PowerCube Diffusion+); PowerCube+ Series (PowerCube Body+ / Diffusion+) (K240706) | Ganshorn Medizin Electronic GmbH | 2024-12-09 |
| Rugged Oxygen Generator (ROG) (RO01-00001) (K240561) | Molecular Products , Ltd. | 2024-12-06 |
| Oxygen Concentrator (ZY-10AB/115) (K240840) | Foshan Care Medical Technology Co., Ltd. | 2024-12-06 |
| iTOF® (K242525) | Nerbio Medical Software Platforms, Inc. | 2024-12-05 |
| Ventoux VC2; Ventoux VC3 (K223120) | Flight Medical Innovations , Ltd. | 2024-12-02 |
| Aluna 2 (K232588) | Knox Medical Diagnostics | 2024-11-25 |
| SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (K241953) | PAJUNK GmbH Medizintechnologie | 2024-11-22 |
| FESL FINK Chamber; FEDL FINK Chamber; FETL FINK Chamber (K240569) | Fink Engineering Pty, Ltd. | 2024-11-21 |
| TD-7301 Spirometer (TD-7301) (K241843) | Gostar Co., Ltd. | 2024-11-20 |
| Besmed Bacterial Filter and HMEF (K241339) | Besmed Health Business Corp | 2024-11-14 |
| RESPOND(R) Ventilator (K241135) | Corvent Medical, Inc. | 2024-11-13 |
| InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (K242775) | Medtronic Minimed | 2024-11-12 |
| AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask (K230915) | Vyaire Medical, Inc. | 2024-11-12 |
| MicroTrend System (K212425) | Exostat Medical, Inc. | 2024-11-07 |
| V80 Anesthetic Vaporizer (V80) (K240375) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-10-31 |
| QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) (K241366) | Dehas Medical Systems GmbH | 2024-10-29 |
| Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask (K241830) | Sleepnet Corporation | 2024-10-18 |
| Ascent Cardiorespiratory Diagnostic Software (K242809) | Medical Graphics Corporation | 2024-10-17 |
| AMStent® Tracheobronchial Covered Stent System (DEN230087) | Peytant Solutions, Inc. | 2024-10-16 |
| UltraEzAir® (UEA1A) (K240114) | Dualams, Inc., Dba Airkor | 2024-10-16 |
| EasyCare Tx 2 (K241939) | Resmed Corp | 2024-09-27 |
| Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (K240163) | Medline Industries, LP | 2024-09-27 |
| myAir (K241216) | Resmed Corp | 2024-09-26 |
| AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System (K234134) | Resmed Pty Ltd (Registration Number: 3004604967) | 2024-09-24 |
| Midas Flowmeter; eAVS (K241465) | Parker Hannifin Corporation | 2024-09-19 |
| STS (K240293) | Techbopulm, Ltd. | 2024-09-17 |
| Sleep Apnea Notification Feature (SANF) (K240929) | Apple, Inc. | 2024-09-13 |
| Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) (K240271) | Linshom Medical, Inc. | 2024-09-11 |
| SonoBlock; SonoBlock II (K241954) | PAJUNK GmbH Medizintechnologie | 2024-09-11 |
| Withings Sleep Rx (K231667) | Withings | 2024-09-06 |
| Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask (K241943) | Sleepnet Corporation | 2024-08-28 |