# K090003: Zetajet

- Pathway: 510(k) (Abbreviated)
- Applicant: Bioject, Inc.
- Decided: Apr 2, 2009 after 90 days
- Product code: KZE (Injector, Fluid, Non-Electrically Powered)
- Device class: 2
- Regulation: 21 CFR 880.5430
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K920631 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Recalls of this device
- Jun 1, 2010 · Not classified · Z-1541-2012: Labeling clarification and software updates to include fixes for end of run summaries, increasing boot reliability, corrections to the double red blood cell count collection TBV limit, and to be in co

## Indications for use
The Zetajet is indicated for delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs into standard injection sites. The Zetajet may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Zetajet may also be used by patients authorized by their physicians to self inject, or have other individuals administer injections of prescribed medication.

Source page: https://510kreport.com/device/K090003
Methodology: https://510kreport.com/methodology