# K060389: Confidose IM Auto-Injector

- Pathway: 510(k) (Traditional)
- Applicant: Pharma-Pen, Inc.
- Decided: Jun 6, 2006 after 112 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: 3 generations back to K860284 (1986). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033696: Personal Injector, Union Medico Aps (2005) Summary page 1.
- K032425: Invisiject Resusable Auto-Injector, Biogen (2003) Summary page 1.
- K042557: Innoject Auto-Injector, Innoject, Inc. (2004) Summary page 1.

## Indications for use
The ConflDoseTM IM auto-injector is a semi-automatic injection system intended to be used for the manual transfer, containment and intramuscular injection of liquid drugs and biologics under the direction of a physician. The ConflDoseTM IM auto-injector system includes an automatic needle retraction mechanism that is intended to aid in the prevention of accidental needle sticks. The ConfiDoseTM IM auto-injector system is intended to mask needle insertion, injection and needle withdrawal from patient view.

Source page: https://510kreport.com/device/K060389
Methodology: https://510kreport.com/methodology