Arya AS200-6
by Caire Inc.
Arya AS200-6 is a Class II device made by Caire Inc., cleared under FDA 510(k) K020324 on 13 Mar 2002 and listed in FDA GUDID since 8 Nov 2021 (UDI-DI M766AS20060), active as of 23 Oct 2026. 3 FDA recalls are linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberM766AS20060 | Date8 Nov 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK020324 | Date13 Mar 2002 | StatusActive |
Official records
- FDA 510(k) database K020324
Across registries
- FDA 510(k) K020324 decided 13 Mar 2002 Active
- FDA GUDID UDI-DI M766AS20060 listed 8 Nov 2021 Listed
Recalls
-
- Completed Z-0478-2025
- Completed Z-0479-2025
Potential failure of affected units to recharge the battery of the oxygen concentrators.
-
- Terminated Z-0768-2013
Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells.
Timeline
- Cleared FDA 510(k) K020324
- Recall initiated FDA recalls Z-0768-2013
- Listed FDA GUDID M766AS20060
- Recall initiated FDA recalls Z-0478-2025
- Recall initiated FDA recalls Z-0479-2025
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Arya
- Generic name
- Mobile/portable oxygen concentrator
- Model / reference
- AS200-6
- Primary DI / UDI-DI
- M766AS20060
- 510(k) Number
- FDA product code
- CAW
- GMDN term
- Mobile/portable oxygen concentrator
- Device class
- Class II
- Regulation number
- 868.5440
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Mobile/portable oxygen concentrator.