BZD · Ventilator, Non-Continuous (Respirator)

Device class

Class II

Regulation 868.5905

Total clearances

2020-06-02 → 2026-07-23

Last 12 months

Unique sponsors

Classification details

Medical specialty

Anesthesiology

Review panel

Regulation number

868.5905

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Resmed Corp	7	3	2026-06-04
Sleepnet Corporation	6	1	2026-01-15
Fisher & Paykel Healthcare, Ltd.	5	0	2025-06-18
Respironics, Inc.	5	0	2023-07-28
Resmed Pty Ltd (Registration Number: 3004604967)	3	0	2024-09-24
BMC Medical Co., Ltd.	3	1	2026-04-29
Resmed Pty , Ltd.	2	0	2025-05-19
RemSleep Holdings, Inc.	2	1	2026-01-07
3B Medical, Inc.	2	0	2022-03-25
Dcstar, Inc.	1	1	2026-05-21
Sleepres, Inc.	1	1	2025-12-15
Apex Medical Corp.	1	0	2020-10-29
Resvent Medical Technology Co., Ltd.	1	1	2026-07-23
Somnetics International, Inc. (Dba Transcend Inc)	1	1	2026-04-17
Suzhou Yuyue Medical Technology Co., Ltd.	1	0	2021-07-02
Philips Respironics	1	0	2024-07-31
Fisher and Paykel Healthcare Limited	1	0	2024-08-23
Genadyne Biotechnologies, Inc.	1	0	2024-12-31
Wellell, Inc.	1	0	2025-05-23
Sysmed (China) Co., Ltd.	1	0	2020-11-25

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
94002	CPT	—	Medium	Non-invasive ventilation, including CPAP/BiPAP; covers non-continuous respirator setup
E0601	HCPCS	Continuous positive airway pressure (cpap) device ✓ CMS-verified description	Medium	CPAP device rental; common billing for non-continuous ventilation equipment

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-23	K253044	Resvent Medical Technology Co., Ltd.	RXiBreeze PAP System (RXiBreeze 20C)
2026-06-04	K253553	Resmed Corp	Orion
2026-05-27	K254104	Resmed Corp	ResScan Essentials
2026-05-21	K251920	Dcstar, Inc.	Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask
2026-04-29	K253166	BMC Medical Co., Ltd.	F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)
2026-04-17	K252338	Somnetics International, Inc. (Dba Transcend Inc)	MySleepDash
2026-01-15	K251847	Sleepnet Corporation	Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask
2026-01-07	K253939	RemSleep Holdings, Inc.	DeltaWave Nasal Pillow System
2025-12-15	K251770	Sleepres, Inc.	SleepRes PAP System
2025-12-05	K251657	Resmed Corp	Personalized Therapy Comfort Settings (PTCS)
2025-06-18	K243583	Fisher & Paykel Healthcare Limited	F&P Nova Nasal Mask
2025-05-28	K250624	Resmed Corp	myAir
2025-05-23	K243023	Wellell, Inc.	WiZARD 520 Full Face Mask
2025-05-19	K242547	Resmed Pty , Ltd.	AirFit F20 Mask System; AirFit F20 NM Mask System
2025-01-15	K242935	BMC Medical Co., Ltd.	Respiration Data Management Software (PAP Link PC)
2024-12-31	K243225	Genadyne Biotechnologies, Inc.	Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)
2024-10-18	K241830	Sleepnet Corporation	Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
2024-09-27	K241939	Resmed Corp	EasyCare Tx 2
2024-09-26	K241216	Resmed Corp	myAir
2024-09-24	K234134	Resmed Pty Ltd (Registration Number: 3004604967)	AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System
2024-08-23	K233829	Fisher and Paykel Healthcare Limited	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)
2024-07-31	K233555	Philips Respironics	AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask
2024-07-10	K241661	Sleepnet Corporation	Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask
2024-07-02	K233415	Remsleep Holdings	DELTAWAVE Nasal Pillows System
2024-06-15	K241469	Sleepnet Corporation	iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask