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Autoject 2

by Owen Mumford USA, Inc. 2 variants

510(k) K945660

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945660 Date11 Aug 1995ClearedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0263-2020 FDA Class II initiated 17 Jul 2019
    • Ongoing Z-0264-2020 FDA Class II initiated 17 Jul 2019

    There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches V14.V976 & V14.W107

    • Terminated Z-1366-2015 FDA Class II initiated 24 Nov 2014

    The syringe carrier is missing components: a damper and spring.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KZH
Device Class
Class II
Regulation
21 CFR Part 880.6920
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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