# K960373: Biojector 2000 Model 1B02000

- Pathway: 510(k) (Traditional)
- Applicant: Bioject, Inc.
- Decided: Mar 5, 1997 after 404 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: 1 generation back to K920631 (1994). 1 ancestor in all.
9 later devices descend from it; 7 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K920631: Bioject Jet Injection System, Bioject, Inc. (1994) Summary page 4.

## 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
- K090959: Lectrajet Needle-Free Injection System, Model: M3 RA (2009), 0 descendants of its own

## Indications for use
The Biojectorg 2000 is indicated for delivery of subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs. The Biojector@ 2040 may be used by physicians, nurses, veterinarians, podiatrists and other practitioners who routinely administer injections. The Biojector* 2000 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/K960373
Methodology: https://510kreport.com/methodology