# K945660: Autoject 2

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford USA, Inc.
- Decided: Aug 11, 1995 after 267 days
- Product code: KZH (Introducer, Syringe Needle)
- Device class: 2
- Regulation: 21 CFR 880.6920
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 5 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K013362: Autoject 2 (2001), 9 descendants of its own
- K033696: Personal Injector (2005), 4 descendants of its own
- K124026: Lobster Auto-Injector (2013), 2 descendants of its own
- K032425: Invisiject Resusable Auto-Injector (2003), 2 descendants of its own
- K042557: Innoject Auto-Injector (2004), 1 descendant of its own

## Recalls of this device
- Jul 17, 2019 · Class II · Z-0264-2020: 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 & 
- Jul 17, 2019 · Class II · Z-0263-2020: 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 & 
- Nov 24, 2014 · Class II · Z-1366-2015: The syringe carrier is missing components: a damper and spring.

Source page: https://510kreport.com/device/K945660
Methodology: https://510kreport.com/methodology