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Aira 100512

by Aira, LLC

Aira 100512 is a Class II device made by Aira, LLC, cleared under FDA 510(k) K071886 on 27 Dec 2007 and listed in FDA GUDID since 20 Aug 2026 (UDI-DI 00810194404658), 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

510(k) K071886

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810194404658 UDI-DI Date20 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK071886 Date27 Dec 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K071886 decided 27 Dec 2007 Active
  • FDA GUDID UDI-DI 00810194404658 listed 20 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K071886
  2. Listed FDA GUDID 00810194404658

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  • Withdrawn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
100512
Primary DI / UDI-DI
00810194404658
510(k) Number
FDA product code
FRG
GMDN term
Sterilization packaging, single-use
Device class
Class II
Regulation number
880.6850
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K071886)

and 8 more cleared under K071886

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

  • Sterilise before use
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)