# K013362: Autoject 2

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford USA, Inc.
- Decided: Nov 13, 2001 after 34 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: 1 generation back to K945660 (1995). 1 ancestor in all.
9 later devices descend from it; 6 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945660: Autoject 2, Owen Mumford USA, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K945567: QC CAP, Medionics International, Inc. (1995). Our OCR of the scanned summary read K945567, FDA’s number for QC CAP (Medionics International, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Autoject 2”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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
- K243232: GripMate (2024), 0 descendants of its own
- K141384: Whisperject Autoinjector (2014), 0 descendants of its own

## Indications for use
The Autoject 2 is a hand held mechanical device intended for a self-administered automated subcutaneous injection of FDA approved drugs. The device is designed for use with a 1ml glass fixed needle syringe, for use in the home by the patient or care-giver to aid and support a recommended treatment regime.

Source page: https://510kreport.com/device/K013362
Methodology: https://510kreport.com/methodology