Who else makes this device?

Name: OxyPAP PAP Device w/o Manometer
Brand: OxyPAP PAP Device w/o Manometer

Anesthesiology › TherapeuticSpirometer, Therapeutic (Incentive)

OxyPAP PAP Device W/o Manometer

The OxyPAP PAP DEVICE w/o MANOMETER is a positive airway pressure (PAP) therapy device which incorporates a positive end expiratory pressure (PEEP) valve and which also has the ability to…

Registry build 21.09.26

The OxyPAP PAP DEVICE w/o MANOMETER is a positive airway pressure (PAP) therapy device which incorporates a positive end expiratory pressure (PEEP) valve and which also has the ability to deliver supplemental oxygen when used with compressed oxygen.

3manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code BWF
Manufacturer	City	Province	Registered as	Device types
Shenzhen Ainengke Electronics Co., Ltd.	Shenzhen	Guangdong	Manufacturer	9
Chinamed Products (China) Ltd.	Gaoyao District	Guangdong	Manufacturer	8
Shenzhen Gwode Technology Co., Ltd.	Shenzhen	Guangdong	Repacker / relabeller	2

Record

Regulatory record for OxyPAP PAP Device w/o Manometer
Listed by	D R Burton Healthcare, LLC, United States
FDA product code	BWF
Device type	Spirometer, Therapeutic (Incentive)
Device class	Class 2
Regulation	21 CFR 868.5690
Establishment	Specification developer, Manufacturer
510(k)	K192000
Record published	2026-04-28
Record revised	2026-05-21 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, manufacturing date
Packaging	Case of 10

Catalogue Numbers

Catalogue numbers for OxyPAP PAP Device w/o Manometer
Catalogue number	Size	Status
1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Portex	ICU Medical, Inc	42
Hudson RCI	Teleflex Medical LLC	26
AirLife™	Airlife, Inc.	11
AIM	Vitalograph Ireland Ltd.	9
AirLife	Carefusion	8
Prochamber Assembly	Respironics Respiratory Drug Delivery (Uk), Ltd.	6
Threshold	Respironics Respiratory Drug Delivery (Uk), Ltd.	6
Curaplex	Bound Tree Medical, LLC	5
Hudson RCI	Medline Industries, Inc.	5
VersaPAP™ Positive Airway Pressure Device	Trudell Medical International	4
Curaplex	TRI-Anim Health Services, Inc.	4
Halyard	Owens & Minor Distribution, Inc.	4

Showing 12 of 67. All products under Spirometer, Therapeutic (Incentive)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K192000	2020-02-19
K160636	2016-08-03

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.