# K082138: Airgent, Model AG7000010

- Pathway: 510(k) (Traditional)
- Applicant: Perfaction, Inc.
- Decided: Jan 23, 2009 after 178 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
Longest line of descent: 2 generations back to K920631 (1994). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960373: Biojector 2000 Model 1B02000, Bioject, Inc. (1997) Summary page 1.
- K003741: Jet Syringe Model-100500, Equidyne Systems, Inc. (2001) Summary page 1.
- K022148: Injex 30 Needle Free Injection System, Equidyne Systems, Inc. (2002) Summary page 2.

## Indications for use
The Airgent System is a needle-free injection system designed for the administration of various medicines and vaccines to the body by means of a high velocity jet of fluid that penetrates the skin The Airgent includes a disposable delivery kit intended for multiple injections on a single patient The Airgent System is indicated for professional use only

Source page: https://510kreport.com/device/K082138
Methodology: https://510kreport.com/methodology