# K945873: Hypex (TM) Jet Injector

- Pathway: 510(k) (Traditional)
- Applicant: Equidyne Systems, Inc.
- Decided: Aug 18, 1995 after 260 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; 3 cite 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K022148: Injex 30 Needle Free Injection System (2002), 1 descendant of its own
- K082138: Airgent, Model AG7000010 (2009), 0 descendants of its own
- K024018: Avant Guardian 101 (2003), 0 descendants of its own
- K020786: Injex Needle-Free Injection System; Rojex Needle-Free Injection System (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K945873
Methodology: https://510kreport.com/methodology