# K042557: Innoject Auto-Injector

- Pathway: 510(k) (Traditional)
- Applicant: Innoject, Inc.
- Decided: Nov 8, 2004 after 49 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 K860284 (1986). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953735: Autoject Mini, Owen Mumford USA, Inc. (1995) Summary page 1.
- K974678: B-D Auto-Injector, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K954729: Pen-Inject 2.25, Scandinavian Health, Ltd. (1996) Summary page 1.
- K945660: Autoject 2, Owen Mumford USA, Inc. (1995) Summary page 1.

## Most influential descendants
- K060389: Confidose IM Auto-Injector (2006), 0 descendants of its own

## Indications for use
The Innoject auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and subcutaneous or intracavernosal injection of liquid drugs and biologics under the direction of a physician and according to approved drug or biologic labeling. The Innoject auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The Innoject auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.

Source page: https://510kreport.com/device/K042557
Methodology: https://510kreport.com/methodology