# K920631: Bioject Jet Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Bioject, Inc.
- Decided: Jun 28, 1994 after 867 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.
18 later devices descend from it; 4 cite it directly.
0 of 19 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
- K960373: Biojector 2000 Model 1B02000 (1997), 9 descendants of its own
- K960285: Medi-Ject Corporation Medi-Jector Needle-Free Bio-Tropin Ddrug Delivery Systems 0.0058/0.0068(Inch Diameter Nozzleorific (1996), 9 descendants of its own
- K962956: Medi-Jector Choice Needle-Free Insulin Delivery System (1996), 5 descendants of its own
- K081532: Pharmajet Needle-Free Injection System (2009), 3 descendants of its own
- K994384: Clicker (2000), 3 descendants of its own

Source page: https://510kreport.com/device/K920631
Methodology: https://510kreport.com/methodology