# K993385: Autojet 2 (Non-Fixed Needle Type)

- Pathway: 510(k) (Traditional)
- Applicant: Owen Mumford USA, Inc.
- Decided: Nov 10, 1999 after 33 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
No predicates in its family tree.
5 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Autoject® 2 (Fixed Needle type): named in the summary without a submission number

## Most influential descendants
- K033696: Personal Injector (2005), 4 descendants of its own
- K124026: Lobster Auto-Injector (2013), 2 descendants of its own
- K243232: GripMate (2024), 0 descendants of its own
- K141384: Whisperject Autoinjector (2014), 0 descendants of its own
- K060389: Confidose IM Auto-Injector (2006), 0 descendants of its own

## Indications for use
A general purpose hand-held mechanical device intended for the subcutaneous injection of Insulin and other approved drugs. The device is designed for use with disposable 1ml non-fixed needle syringe and to accommodate self use in the horne by the patient in order to aid and support compliance with the recommended treatment regime,

Source page: https://510kreport.com/device/K993385
Methodology: https://510kreport.com/methodology