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Inrad 54122

by Inrad

Inrad 54122 is a Class I device made by Inrad, cleared under FDA 510(k) K813368 on 5 Jan 1982 and listed in FDA GUDID since 9 Oct 2026 (UDI-DI 00817295020367), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K813368

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 Number00817295020367 UDI-DI Date9 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK813368 Date5 Jan 1982DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K813368 decided 5 Jan 1982 Active
  • FDA GUDID UDI-DI 00817295020367 listed 9 Oct 2026 Listed

Recalls

1 recall · FDA

    • Terminated Z-1063-2011 FDA Unclassified (pre-2012) initiated 20 Dec 2010

    This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date.

Timeline

3 dated events

  1. Cleared FDA 510(k) K813368
  2. Recall initiated FDA recalls Z-1063-2011
  3. Listed FDA GUDID 00817295020367

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Inrad
Generic name
Body aspiration needle, single-use
Model / Ref / Catalog
54122
Primary DI / UDI-DI
00817295020367
510(k) Number
FDA product code
GAA
GMDN term
Body aspiration needle, single-use
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K813368)

and 8 more cleared under K813368

Similar devices

Other devices filed under FDA product code GAA (Needle, Aspiration And Injection, Disposable).

Other devices from Inrad

  • Inrad 53220

    Class I

  • Inrad 53222

    Class I

  • Inrad 53218

    Class I

  • Inrad 41222

    Class I

See all devices from Inrad →

Properties

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