# K032425: Invisiject Resusable Auto-Injector

- Pathway: 510(k) (Traditional)
- Applicant: Biogen
- Decided: Nov 5, 2003 after 91 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). 4 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K974678: B-D Auto-Injector, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K013362: Autoject 2, Owen Mumford USA, Inc. (2001)
- (no number) standard Piston Syringe: named in the summary without a submission number
- (no number) Meridian's EpiPen: named in the summary without a submission number

## Most influential descendants
- 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 Invisijectr" Reusable Auto-Injector is a reusable device indicated for use by the patient to assist with the self-administered injection of a fixed dose of AVONE? from a pre-filled syringe through a single lumen hypodermic needle. The auto-injectors are intended to be used in any setting including the home.

Source page: https://510kreport.com/device/K032425
Methodology: https://510kreport.com/methodology