# K041239: Genesis Medical Technologies, Inc. Pharmajet Needle-Free Injector, Model M2000

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Medical Technology, Inc.
- Decided: Nov 8, 2004 after 181 days
- Product code: KZE (Injector, Fluid, Non-Electrically Powered)
- Device class: 2
- Regulation: 21 CFR 880.5430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081532: Pharmajet Needle-Free Injection System (2009), 3 descendants of its own
- K110456: Pharmajet 0.1 ML Intradermal Needle-Free Injection System (2011), 1 descendant of its own
- K121270: Bioject Needle-Free Injection Management System (2012), 0 descendants of its own
- K111517: Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector Catalog 501-10, Stratis Reset Stati (2011), 0 descendants of its own

## Indications for use
The GMTI PharmaJet System is intended to deliver various predetermined medicines and vaccines either intramuscularly or subcutaneously by means of a narrow, high velocity fluid jet which penetrates the surface of the skin and delivers the medicine or vaccine to the body.

Source page: https://510kreport.com/device/K041239
Methodology: https://510kreport.com/methodology