DeVilbiss
Sleep Flow Generator Accessories Product Description IntelliPAP 12V Adapter with Clips
22manufacturers in China registered for this device type
50catalogue numbers in this listing
3510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Guangdong (5), Beijing (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Foshan Kycare Medical Equipment Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 3 |
| Jakamed Instruments Co., Ltd. | Changsha | Hunan | Contract manufacturer | 2 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Jiangsu Yuyue Medical Equipment & Supply Company Limited | Jiangsu | Jiangsu | Contract manufacturer | 17 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Danyang Huayi Medical Supply & Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 11 |
| Shandong Moonlight Electronics Tech Co., Ltd. | Weifang | Shandong | Manufacturer | 11 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| Beijing Choicemmed Technology Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 9 |
| Foshan Care Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
| Zhengzhou Olive Electronic Technology Co., Ltd. | Zhengzhou | Henan | Manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Generator, Oxygen, Portable
Record
| Listed by | DeVilbiss Healthcare LLC., United States |
|---|---|
| FDA product code | CAW |
| Device type | Generator, Oxygen, Portable |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5440 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K053240 |
| Record published | 2016-09-08 |
| Record revised | 2026-07-31 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C |
| Distribution end date | 2024-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 535D-D-870 | In distribution | |
| 125D-ARYA-XB | In distribution | |
| 555KS | In distribution | |
| 1025DS | In distribution | |
| 125D-BT-XB | In distribution | |
| 535D-E-CF | In distribution | |
| DV6X-619 | In distribution | |
| 535D-D-CF | In distribution | |
| 535D-C-870 | In distribution | |
| 525DS-Q | In distribution | |
| 535D-M6-CF | In distribution | |
| 125D-XB | In distribution | |
| 555PS | In distribution | |
| 525DS | In distribution | |
| 555DS | In distribution | |
| 535D-C-CF | In distribution | |
| 125D | In distribution | |
| 535D-M6-870 | In distribution | |
| 125D-BT | In distribution | |
| 535C-D-870 | Withdrawn | |
| 535I-E-CF | Withdrawn | |
| 525KS | Withdrawn | |
| 535C-M6-870 | Withdrawn | |
| 535C-C-870 | Withdrawn | |
| DV51I-670 | Withdrawn | |
| 1025KS | Withdrawn | |
| 444-582 | Withdrawn | |
| 535C-E-CF | Withdrawn | |
| 535D-ML6-CF | Withdrawn | |
| DV51D-683 | Withdrawn | |
| 1025UK | Withdrawn | |
| 535D-ML6-870 | Withdrawn | |
| 535C-D-CF | Withdrawn | |
| 1025KS | Withdrawn | |
| 535D-E-870 | Withdrawn | |
| 535D-M4-870 | Withdrawn | |
| 515A-621 | Withdrawn | |
| 535I-D-CF | Withdrawn | |
| 535I-C-CF | Withdrawn | |
| 535D-C-CF-RE | Withdrawn | |
| 525PS | Withdrawn | |
| 125K-XB | Withdrawn | |
| 535I-ML6-CF | Withdrawn | |
| DV51D-681 | Withdrawn | |
| 535C-M6-CF | Withdrawn | |
| 535C-C-CF | Withdrawn | |
| 505DZ-643 | Withdrawn | |
| DV51D-696 | Withdrawn | |
| 535C-ML6-CF | Withdrawn | |
| 535D-E-870 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EverFlo | Respironics Inc. | 32 |
| Mark 5 Nuvo Lite | Nidek Medical Products, Inc. | 30 |
| SimplyGo Mini | Respironics Inc. | 26 |
| X-PLO2R | Belluscura, LLC | 17 |
| Mark 5 Nuvo 8 | Nidek Medical Products, Inc. | 12 |
| ViveBreathe | Vive Health LLC | 11 |
| Invacare® HomeFill® Oxygen System | Invacare GmbH | 11 |
| Discov-R | Belluscura, LLC | 11 |
| NewLife Elite | Caire Inc. | 10 |
| NewLife Elite | Airsep Corp. | 10 |
| Rhythm Healthcare | Qingdao Kingon Medical Science AND Technology Co., Ltd. | 9 |
| OxyGo | Mv Life, LLC | 9 |
Showing 12 of 187. All products under Generator, Oxygen, Portable
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253549 | 2026-03-26 |
| K250805 | 2025-12-09 |
| K172648 | 2018-03-23 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medical Depot, Inc. | 510(k) number | 2025-04-11 | Class I | Nonconforming Material/Component | Potential for DC Power Supply housing to become hot to the touch and deform the plastic housing. | 89,532 units | |
| DeVilbiss Healthcare LLC. | 510(k) number | 2023-03-09 | Class II | Labeling design | The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. | 143,397 units | |
| DeVilbiss Healthcare LLC. | 510(k) number | 2022-11-18 | Class II | Labeling False and Misleading | The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit) | 1004315 (US); 414559 (OUS) | |
| DeVilbiss Healthcare LLC. | 510(k) number | 2022-09-19 | Class II | Under Investigation by firm | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) | 48 units | |
| DeVilbiss Healthcare LLC. | 510(k) number | 2006-08-24 | Not classified | Other | Potential for oxygen cylinders to not fill completely | 252 units | 2009-08-27 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-10-30 | Not classified | Device Design | potential for sieve beds to have been incorrectly assembled | 428 units | 2012-10-27 |
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.