# K122837: Autoject 2 for Glassy Syringe

- Pathway: 510(k) (Special)
- Applicant: Owen Mumford, Ltd.
- Decided: Oct 15, 2012 after 28 days
- Product code: KZH (Introducer, Syringe Needle)
- Device class: 2
- Regulation: 21 CFR 880.6920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945660 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013362: Autoject 2, Owen Mumford USA, Inc. (2001) Summary page 1.

## Indications for use
The Autoject 11 for glass syringe is a non-sterile fully automatic injection device. The device utilises a 1 ml fixed needle pre-filled glass syringe. The Autoject 11 for glass syringe is capable of subcutaneous delivery of an FDA approved drug.

Source page: https://510kreport.com/device/K122837
Methodology: https://510kreport.com/methodology