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Aira 100538

by Aira, LLC

Aira 100538 is a Class II device made by Aira, LLC, cleared under FDA 510(k) K143637 on 9 Sep 2015 (1 earlier submission) and listed in FDA GUDID since 16 Jan 2026 (UDI-DI 00810194400698), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810194400698 UDI-DI Date16 Jan 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143637 Date9 Sep 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143637 decided 9 Sep 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00810194400698 listed 16 Jan 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K071886
  2. Cleared FDA 510(k) K143637
  3. Listed FDA GUDID 00810194400698

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Aira
Generic name
Sterilization packaging, single-use
Model / reference
100538
Primary DI / UDI-DI
00810194400698
510(k) Number
FDA product code
FRG, JOJ
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850, 880.2800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K071886)

and 8 more cleared under K071886

Cleared under the same submission (K143637)

and 8 more cleared under K143637

Similar devices

Other devices filed under FDA product code FRG (Wrap, Sterilization).

Other devices from Aira, LLC

  • Aira 119132

    Class I

  • Aira 119133

    Class I

  • Aira 119134

    Class I

  • Aira 119144

    Class I

See all devices from Aira, LLC →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)