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Arya AS200-106

by Caire Inc.

Arya AS200-106 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 M766AS2001060), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K020324

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberM766AS2001060 UDI-DI Date8 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020324 Date13 Mar 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020324 decided 13 Mar 2002 Active
  • FDA GUDID UDI-DI M766AS2001060 listed 8 Nov 2021 Listed

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Completed Z-0478-2025 FDA Class II initiated 4 Oct 2024
    • Completed Z-0479-2025 FDA Class II initiated 4 Oct 2024

    Potential failure of affected units to recharge the battery of the oxygen concentrators.

    • Terminated Z-0768-2013 FDA Class II initiated 14 Jan 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

5 dated events

  1. Cleared FDA 510(k) K020324
  2. Recall initiated FDA recalls Z-0768-2013
  3. Listed FDA GUDID M766AS2001060
  4. Recall initiated FDA recalls Z-0478-2025
  5. Recall initiated FDA recalls Z-0479-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arya
Generic name
Mobile/portable oxygen concentrator
Model / reference
AS200-106
Primary DI / UDI-DI
M766AS2001060
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

Related devices

Category: Mobile/portable oxygen concentrator

Cleared under the same submission (K020324)

and 8 more cleared under K020324

Similar devices in this category

Other devices filed under Mobile/portable oxygen concentrator.

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)