FDA Product Code
FDA Product Code BZD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5905
510(k) Clearances — 462 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261262 | Altis Full Face Mask | Respironics, Inc. | 2026-09-25 | Traditional | PDF ↗ |
| K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | 2026-07-23 | Traditional | PDF ↗ |
| K253553 | Orion | Resmed Corp | 2026-06-04 | Traditional | PDF ↗ |
| K254104 | ResScan Essentials | Resmed Corp | 2026-05-27 | Traditional | PDF ↗ |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. | 2026-05-21 | Traditional | PDF ↗ |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | 2026-04-29 | Traditional | PDF ↗ |
| K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | 2026-04-17 | Traditional | PDF ↗ |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | 2026-01-15 | Traditional | PDF ↗ |
| K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | 2026-01-07 | Special | PDF ↗ |
| K251770 | SleepRes PAP System | Sleepres, Inc. | 2025-12-15 | Traditional | PDF ↗ |
| K251657 | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp | 2025-12-05 | Traditional | PDF ↗ |
| K243583 | F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited | 2025-06-18 | Traditional | PDF ↗ |
| K250624 | myAir | Resmed Corp | 2025-05-28 | Traditional | PDF ↗ |
| K243023 | WiZARD 520 Full Face Mask | Wellell, Inc. | 2025-05-23 | Traditional | PDF ↗ |
| K242547 | AirFit F20 Mask System; AirFit F20 NM Mask System | Resmed Pty , Ltd. | 2025-05-19 | Traditional | PDF ↗ |
| K242935 | Respiration Data Management Software (PAP Link PC) | BMC Medical Co., Ltd. | 2025-01-15 | Traditional | PDF ↗ |
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L) | Genadyne Biotechnologies, Inc. | 2024-12-31 | Special | PDF ↗ |
| K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | Sleepnet Corporation | 2024-10-18 | Traditional | PDF ↗ |
| K241939 | EasyCare Tx 2 | Resmed Corp | 2024-09-27 | Traditional | PDF ↗ |
| K241216 | myAir | Resmed Corp | 2024-09-26 | Traditional | PDF ↗ |
| K234134 | AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | 2024-09-24 | Traditional | PDF ↗ |
| K233829 | 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) | Fisher and Paykel Healthcare Limited | 2024-08-23 | Traditional | PDF ↗ |
| K233555 | AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask | Philips Respironics | 2024-07-31 | Traditional | PDF ↗ |
| K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | Sleepnet Corporation | 2024-07-10 | Special | PDF ↗ |
| K233415 | DELTAWAVE Nasal Pillows System | Remsleep Holdings | 2024-07-02 | Traditional | PDF ↗ |
| K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | Sleepnet Corporation | 2024-06-15 | Special | PDF ↗ |
| K230476 | Oran Park Mask | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-10-19 | Traditional | PDF ↗ |
| K231313 | Therapy Mask 3100 NC/SP | Respironics, Inc. | 2023-07-28 | Special | PDF ↗ |
| K223747 | Whitsundays Mask System | Resmed Pty Ltd (Registration Number: 3004604967) | 2023-07-06 | Traditional | PDF ↗ |
| K221436 | F&P 950 Accessory Breathing Circuit Kits | Fisher & Paykel Healthcare, Ltd. | 2023-06-29 | Traditional | PDF ↗ |
| K223696 | F&P Solo Mask Range | Fisher & Paykel Healthcare, Ltd. | 2023-05-17 | Traditional | PDF ↗ |
| K212263 | Luna G3 BPAP System | 3B Medical, Inc. | 2022-03-25 | Traditional | PDF ↗ |
| K212371 | F&P Evora Full Face Mask | Fisher & Paykel Healthcare, Ltd. | 2022-03-18 | Traditional | PDF ↗ |
| K211155 | Auto CPAP System | BMC Medical Co., Ltd. | 2022-03-09 | Traditional | PDF ↗ |
| K211274 | iQ 2 Nasal Mask, Phantom 2 Nasal Mask | Sleepnet Corporation | 2022-01-10 | Traditional | PDF ↗ |
| K210844 | DreamWear Silicone Pillows Mask | Respironics, Inc. | 2021-08-24 | Traditional | PDF ↗ |
| K210386 | Magneto Nasal Mask | Respironics, Inc. | 2021-07-12 | Traditional | PDF ↗ |
| K203347 | 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 | Suzhou Yuyue Medical Technology Co., Ltd. | 2021-07-02 | Traditional | PDF ↗ |
| K203601 | Innova Nasal Non-Vented Mask | Sleepnet Corporation | 2021-04-30 | Traditional | PDF ↗ |
| K201620 | Luna® G3 BPAP 25A | 3B Medical, Inc. | 2021-01-29 | Traditional | PDF ↗ |
| K200565 | Galapogos | Resmed Corp | 2021-01-17 | Traditional | PDF ↗ |
| K203126 | S10 Kirra | Resmed Pty , Ltd. | 2020-12-18 | Traditional | PDF ↗ |
| K192177 | SysMed S/T | Sysmed (China) Co., Ltd. | 2020-11-25 | Traditional | PDF ↗ |
| K193206 | WiZARD 510 Nasal Mask | Apex Medical Corp. | 2020-10-29 | Traditional | PDF ↗ |
| K201439 | Ventilator, Non-continuous (Respirator) | Respironics, Inc. | 2020-09-25 | Traditional | PDF ↗ |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Respironics, Inc. | 2020-07-10 | Traditional | PDF ↗ |
| K200089 | 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 | Fisher & Paykel Healthcare, Ltd. | 2020-06-02 | Traditional | PDF ↗ |
| K183226 | Care Orchestrator Essence | Respironics, Inc. | 2019-10-18 | Traditional | PDF ↗ |
| K190713 | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) | Fisher & Paykel Healthcare, Ltd. | 2019-10-11 | Traditional | PDF ↗ |
| K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask | Sleepnet Corporation | 2019-07-05 | Traditional | PDF ↗ |
| K182394 | WiZARD 310/320 Series CPAP Mask | Apex Medical Corp. | 2019-05-17 | Traditional | PDF ↗ |
| K183512 | Moore Park Mask | Resmed, Ltd. | 2019-05-07 | Traditional | PDF ↗ |
| K181053 | Care Orchestrator | Respironics, Inc. | 2019-01-04 | Traditional | PDF ↗ |
| K180388 | Transcend 365 miniCPAP System | Somnetics International, Inc. | 2018-11-30 | Traditional | PDF ↗ |
| K173193 | F&P SleepStyle | Fisher & Paykel Healthcare, Ltd. | 2018-08-08 | Traditional | PDF ↗ |
| K180497 | Scone Mask | Resmed, Ltd. | 2018-06-15 | Traditional | PDF ↗ |
| K172335 | Bleep DreamPort | Snapcpap | 2018-03-30 | Traditional | PDF ↗ |
| K170924 | AirFit F20 | Resmed, Ltd. | 2018-01-03 | Traditional | PDF ↗ |
| K171212 | AirFit N20 | Resmed, Ltd. | 2017-09-28 | Traditional | PDF ↗ |
| K163464 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) | Bmc Medical., Ltd. | 2017-09-05 | Traditional | PDF ↗ |
| K162905 | SleepWeaver 3D Nasal Mask | Circadiance, LLC | 2017-03-15 | Traditional | PDF ↗ |
| K161686 | F&P InfoSmart | Fisher & Paykel Healthcare, Ltd. | 2017-01-24 | Traditional | PDF ↗ |
| K161412 | F&P Brevida Nasal Pillows Mask | Fisher & Paykel Healthcare, Ltd. | 2017-01-18 | Traditional | PDF ↗ |
| K160836 | Menai System | Resmed, Ltd. | 2016-12-15 | Traditional | PDF ↗ |
| K161978 | AirFit N20 | Resmed, Ltd. | 2016-11-17 | Traditional | PDF ↗ |
| K160127 | iCodeConnect | 3B Medical, Inc. | 2016-11-10 | Traditional | PDF ↗ |
| K153505 | F&P Eson 2 Nasal Mask | Fisher & Paykel Healthcare Limited | 2016-09-20 | Traditional | PDF ↗ |
| K160822 | S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV | Resmed, Ltd. | 2016-09-09 | Traditional | PDF ↗ |
| K153387 | Luna CPAP and Auto CPAP System | 3B Medical, Inc. | 2016-09-08 | Traditional | PDF ↗ |
| K153563 | AirFit F20 | Resmed, Ltd. | 2016-05-13 | Traditional | PDF ↗ |
| K153673 | AirFit N20 | Resmed, Ltd. | 2016-05-02 | Traditional | PDF ↗ |
| K151120 | Simple T Pediatric Nasal Mask | Respironics, Inc. | 2016-04-15 | Abbreviated | PDF ↗ |
| K151683 | SleepWeaver Advance Pediatric Nasal CPAP Mask | Circadiance, LLC | 2016-04-05 | Traditional | PDF ↗ |
| K152810 | DeVilbiss DV6WM Wireless Modem | Devilbiss Healthcare, LLC | 2016-01-21 | Traditional | PDF ↗ |
| K152356 | Sapphire | Respironics, Inc. | 2016-01-08 | Traditional | PDF ↗ |
| K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE | Devilbiss Healthcare, LLC | 2015-09-18 | Traditional | PDF ↗ |
| K150639 | AF541 EE Full Face Mask | Respironics, Inc. | 2015-09-18 | Abbreviated | PDF ↗ |
| K150111 | Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series | Apex Medical Corp. | 2015-09-15 | Traditional | PDF ↗ |
| K150685 | Skynector CPAP Mask | Sky Wise Medical Instrument (Shen Zhen) Co., Ltd. | 2015-08-24 | Traditional | PDF ↗ |
| K143700 | CPAP Cannulaide | Salter Labs | 2015-08-05 | Traditional | PDF ↗ |
| K150365 | Cloud9 System | Insleep Technologies, LLC | 2015-07-21 | Traditional | PDF ↗ |
| K143603 | Darlinghurst Vented, Darlinghurst NV-AAV | Resmed, Ltd. | 2015-05-21 | Traditional | PDF ↗ |
| K141770 | LUNA CPAP AND AUTO-CPAP SYSTEM | 3B Medical, Inc. | 2015-04-22 | Traditional | PDF ↗ |
| K140980 | TI NASAL MASK | Respironics, Inc. | 2015-02-10 | Abbreviated | PDF ↗ |
| K140580 | REVOLUTION FULLFACE MASK | Respironics Inc. (Dba Philips Respironics) | 2015-01-16 | Traditional | PDF ↗ |
| K142554 | Revolution Full Face Mask | Respironics, Inc. | 2015-01-09 | Abbreviated | PDF ↗ |
| K140268 | SIMPLE T YOUTH NASAL MASK | Respironics, Inc. | 2014-10-20 | Abbreviated | PDF ↗ |
| K141152 | ADVANTAGE | Stevenson Industries, Inc. | 2014-10-17 | Traditional | PDF ↗ |
| K140929 | Z1 CPAP SYSTEM | Human Design Medical, LLC | 2014-10-17 | Traditional | PDF ↗ |
| K141522 | APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES | Apex Medical Corp. | 2014-10-06 | Traditional | PDF ↗ |
| K133769 | 3B RESMART BPAP 25A, BMC RESMART BPAP 25A | 3B Medical, Inc. | 2014-08-25 | Traditional | PDF ↗ |
| K140880 | DEVILBISS SMARTLINK II SYSTEM | Devilbiss Healthcare, LLC | 2014-08-04 | Traditional | PDF ↗ |
| K140279 | S9 GREENHILLS | Resmed, Ltd. | 2014-07-31 | Traditional | PDF ↗ |
| K140159 | S9 WANDA VPAP ST | Resmed, Ltd. | 2014-06-17 | Traditional | PDF ↗ |
| K132901 | AIRSOFT F15 | Resmed, Ltd. | 2014-06-09 | Traditional | PDF ↗ |
| K140054 | RESCAN | Resmed, Ltd. | 2014-05-16 | Traditional | PDF ↗ |
| K140124 | S9 ELOUERA | Resmed Corp | 2014-05-12 | Traditional | PDF ↗ |
| K133009 | NASAL MASK, NASAL MASK, FULL FACE MASK | BMC Medical Co., Ltd. | 2014-04-23 | Traditional | PDF ↗ |
| K130828 | K SERIES CPAP SYSTEMS | Curative Medical, Inc. | 2014-01-13 | Traditional | PDF ↗ |
| K132606 | S9 CRONULLA FOR HER | Resmed, Ltd. | 2014-01-13 | Traditional | PDF ↗ |
Product code BZD · Class II · Anesthesiology. Data: openFDA.