| RXiBreeze PAP System (RXiBreeze 20C) (K253044) | Resvent Medical Technology Co., Ltd. | 2026-07-23 |
| Orion (K253553) | Resmed Corp | 2026-06-04 |
| ResScan Essentials (K254104) | Resmed Corp | 2026-05-27 |
| Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask (K251920) | Dcstar, Inc. | 2026-05-21 |
| F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) (K253166) | BMC Medical Co., Ltd. | 2026-04-29 |
| MySleepDash (K252338) | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 |
| Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask (K251847) | Sleepnet Corporation | 2026-01-15 |
| DeltaWave Nasal Pillow System (K253939) | RemSleep Holdings, Inc. | 2026-01-07 |
| SleepRes PAP System (K251770) | Sleepres, Inc. | 2025-12-15 |
| Personalized Therapy Comfort Settings (PTCS) (K251657) | Resmed Corp | 2025-12-05 |
| F&P Nova Nasal Mask (K243583) | Fisher & Paykel Healthcare Limited | 2025-06-18 |
| myAir (K250624) | Resmed Corp | 2025-05-28 |
| WiZARD 520 Full Face Mask (K243023) | Wellell, Inc. | 2025-05-23 |
| AirFit F20 Mask System; AirFit F20 NM Mask System (K242547) | Resmed Pty , Ltd. | 2025-05-19 |
| Respiration Data Management Software (PAP Link PC) (K242935) | BMC Medical Co., Ltd. | 2025-01-15 |
| 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 |
| 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 |
| EasyCare Tx 2 (K241939) | Resmed Corp | 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 |
| Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA) (K233829) | Fisher and Paykel Healthcare Limited | 2024-08-23 |
| AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask (K233555) | Philips Respironics | 2024-07-31 |
| Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask (K241661) | Sleepnet Corporation | 2024-07-10 |
| DELTAWAVE Nasal Pillows System (K233415) | Remsleep Holdings | 2024-07-02 |
| iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask (K241469) | Sleepnet Corporation | 2024-06-15 |
| Oran Park Mask (K230476) | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-10-19 |
| Therapy Mask 3100 NC/SP (K231313) | Respironics, Inc. | 2023-07-28 |
| Whitsundays Mask System (K223747) | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-07-06 |
| F&P 950 Accessory Breathing Circuit Kits (K221436) | Fisher & Paykel Healthcare, Ltd. | 2023-06-29 |
| F&P Solo Mask Range (K223696) | Fisher & Paykel Healthcare, Ltd. | 2023-05-17 |
| Luna G3 BPAP System (K212263) | 3B Medical, Inc. | 2022-03-25 |
| F&P Evora Full Face Mask (K212371) | Fisher & Paykel Healthcare, Ltd. | 2022-03-18 |
| Auto CPAP System (K211155) | BMC Medical Co., Ltd. | 2022-03-09 |
| iQ 2 Nasal Mask, Phantom 2 Nasal Mask (K211274) | Sleepnet Corporation | 2022-01-10 |
| DreamWear Silicone Pillows Mask (K210844) | Respironics, Inc. | 2021-08-24 |
| Magneto Nasal Mask (K210386) | Respironics, Inc. | 2021-07-12 |
| Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask (K203347) | Suzhou Yuyue Medical Technology Co., Ltd. | 2021-07-02 |
| Innova Nasal Non-Vented Mask (K203601) | Sleepnet Corporation | 2021-04-30 |
| Luna® G3 BPAP 25A (K201620) | 3B Medical, Inc. | 2021-01-29 |
| Galapogos (K200565) | Resmed Corp | 2021-01-17 |
| S10 Kirra (K203126) | Resmed Pty , Ltd. | 2020-12-18 |
| SysMed S/T (K192177) | Sysmed (China) Co., Ltd. | 2020-11-25 |
| WiZARD 510 Nasal Mask (K193206) | Apex Medical Corp. | 2020-10-29 |
| Ventilator, Non-continuous (Respirator) (K201439) | Respironics, Inc. | 2020-09-25 |
| DreamStation 2 System, DreamStation 2 Advanced System (K200480) | Respironics, Inc. | 2020-07-10 |
| F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model (K200089) | Fisher & Paykel Healthcare, Ltd. | 2020-06-02 |
| Care Orchestrator Essence (K183226) | Respironics, Inc. | 2019-10-18 |
| F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) (K190713) | Fisher & Paykel Healthcare, Ltd. | 2019-10-11 |
| Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask (K190254) | Sleepnet Corporation | 2019-07-05 |
| WiZARD 310/320 Series CPAP Mask (K182394) | Apex Medical Corp. | 2019-05-17 |
| Moore Park Mask (K183512) | Resmed, Ltd. | 2019-05-07 |
| Care Orchestrator (K181053) | Respironics, Inc. | 2019-01-04 |
| Transcend 365 miniCPAP System (K180388) | Somnetics International, Inc. | 2018-11-30 |
| F&P SleepStyle (K173193) | Fisher & Paykel Healthcare, Ltd. | 2018-08-08 |
| Scone Mask (K180497) | Resmed, Ltd. | 2018-06-15 |
| Bleep DreamPort (K172335) | Snapcpap | 2018-03-30 |
| AirFit F20 (K170924) | Resmed, Ltd. | 2018-01-03 |
| AirFit N20 (K171212) | Resmed, Ltd. | 2017-09-28 |
| Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) (K163464) | Bmc Medical., Ltd. | 2017-09-05 |
| SleepWeaver 3D Nasal Mask (K162905) | Circadiance, LLC | 2017-03-15 |
| F&P InfoSmart (K161686) | Fisher & Paykel Healthcare, Ltd. | 2017-01-24 |
| F&P Brevida™ Nasal Pillows Mask (K161412) | Fisher & Paykel Healthcare, Ltd. | 2017-01-18 |
| Menai System (K160836) | Resmed, Ltd. | 2016-12-15 |
| AirFit N20 (K161978) | Resmed, Ltd. | 2016-11-17 |
| iCodeConnect (K160127) | 3B Medical, Inc. | 2016-11-10 |
| F&P Eson 2 Nasal Mask (K153505) | Fisher & Paykel Healthcare Limited | 2016-09-20 |
| S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV (K160822) | Resmed, Ltd. | 2016-09-09 |
| Luna CPAP and Auto CPAP System (K153387) | 3B Medical, Inc. | 2016-09-08 |
| AirFit F20 (K153563) | Resmed, Ltd. | 2016-05-13 |
| AirFit N20 (K153673) | Resmed, Ltd. | 2016-05-02 |
| Simple T Pediatric Nasal Mask (K151120) | Respironics, Inc. | 2016-04-15 |
| SleepWeaver Advance Pediatric Nasal CPAP Mask (K151683) | Circadiance, LLC | 2016-04-05 |
| DeVilbiss DV6WM Wireless Modem (K152810) | Devilbiss Healthcare, LLC | 2016-01-21 |
| Sapphire (K152356) | Respironics, Inc. | 2016-01-08 |
| AF541 EE Full Face Mask (K150639) | Respironics, Inc. | 2015-09-18 |
| DeVilbiss Intellipap2/DeVilbiss BLUE (K143677) | Devilbiss Healthcare, LLC | 2015-09-18 |
| Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series (K150111) | Apex Medical Corp. | 2015-09-15 |
| Skynector CPAP Mask (K150685) | Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. | 2015-08-24 |
| CPAP Cannulaide (K143700) | Salter Labs | 2015-08-05 |
| Cloud9 System (K150365) | Insleep Technologies, LLC | 2015-07-21 |
| Darlinghurst Vented, Darlinghurst NV-AAV (K143603) | Resmed, Ltd. | 2015-05-21 |
| LUNA CPAP AND AUTO-CPAP SYSTEM (K141770) | 3B Medical, Inc. | 2015-04-22 |
| TI NASAL MASK (K140980) | Respironics, Inc. | 2015-02-10 |
| REVOLUTION FULLFACE MASK (K140580) | Respironics Inc. (Dba Philips Respironics) | 2015-01-16 |
| Revolution Full Face Mask (K142554) | Respironics, Inc. | 2015-01-09 |
| SIMPLE T YOUTH NASAL MASK (K140268) | Respironics, Inc. | 2014-10-20 |
| ADVANTAGE (K141152) | Stevenson Industries, Inc. | 2014-10-17 |
| Z1 CPAP SYSTEM (K140929) | Human Design Medical, LLC | 2014-10-17 |
| APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES (K141522) | Apex Medical Corp. | 2014-10-06 |
| 3B RESMART BPAP 25A, BMC RESMART BPAP 25A (K133769) | 3B Medical, Inc. | 2014-08-25 |
| DEVILBISS SMARTLINK II SYSTEM (K140880) | Devilbiss Healthcare, LLC | 2014-08-04 |
| S9 GREENHILLS (K140279) | Resmed, Ltd. | 2014-07-31 |
| S9 WANDA VPAP ST (K140159) | Resmed, Ltd. | 2014-06-17 |
| AIRSOFT F15 (K132901) | Resmed, Ltd. | 2014-06-09 |
| RESCAN (K140054) | Resmed, Ltd. | 2014-05-16 |
| S9 ELOUERA (K140124) | Resmed Corp | 2014-05-12 |
| NASAL MASK, NASAL MASK, FULL FACE MASK (K133009) | BMC Medical Co., Ltd. | 2014-04-23 |
| K SERIES CPAP SYSTEMS (K130828) | Curative Medical, Inc. | 2014-01-13 |
| S9 CRONULLA FOR HER (K132606) | Resmed, Ltd. | 2014-01-13 |
| IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 (K131901) | 3B Medical, Inc. | 2013-12-23 |