# K974678: B-D Auto-Injector

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: May 29, 1998 after 165 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 K860284 (1986). 1 ancestor in all.
4 later devices descend from it; 2 cite 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)
- K860284: Diamatic, Automatic Insulin Injector, Ulster Scientific, Inc. (1986) Summary page 2.

## Most influential descendants
- K032425: Invisiject Resusable Auto-Injector (2003), 2 descendants of its own
- K042557: Innoject Auto-Injector (2004), 1 descendant of its own
- K060389: Confidose IM Auto-Injector (2006), 0 descendants of its own
- K042314: Syringe Grip for the Avonex Pre-Filled Syringe (2004), 0 descendants of its own

## Indications for use
The B-D® Auto-Injector is indicated for assisting the injection of a fixed dose of an approved drug or biologic packaged in a HYPAK® Cartridge component which contains a HYPAK® syringe prefilled with the drug or biologic.

Source page: https://510kreport.com/device/K974678
Methodology: https://510kreport.com/methodology