# K033696: Personal Injector

- Pathway: 510(k) (Traditional)
- Applicant: Union Medico Aps
- Decided: Feb 16, 2005 after 449 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 K945660 (1995). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993385: Autojet 2 (Non-Fixed Needle Type), Owen Mumford USA, Inc. (1999)
- K013362: Autoject 2, Owen Mumford USA, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
Personal Injector is intended for use by patients to self-administer or by care-givers for injection of FDA approved drugs or biologics. Personal Injector is intended to introduce the needle below the skin surface. Personal Injector is designed to accommodate two different and replaceable syringe-holders. Personal Injector is intended for the use with FDA approved fixed or non-fixed needle syringes supplied with specific injection regimens. Personal Injector is intended to be used in any setting including the home.

Source page: https://510kreport.com/device/K033696
Methodology: https://510kreport.com/methodology