# K121270: Bioject Needle-Free Injection Management System

- Pathway: 510(k) (Traditional)
- Applicant: Bioject Medical Technologies, Inc.
- Decided: Jul 19, 2012 after 84 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: 4 generations back to K920631 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 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.
- K980580: Becton Dickinson Syringes, Bd Becton Dickinson Vacutainer Systems Preanalytic (1998) Summary page 1.
- K771203: Disp. Hypodermic Needle, Terumo America, Inc. (1977) Summary page 1.
- K110456: Pharmajet 0.1 ML Intradermal Needle-Free Injection System, Pharmajet, Inc. (2011) Summary page 1.

## Indications for use
The Biojector® 2000 is indicated for delivery of subcutaneous (SC), intramuscular (IM)or intradermal (ID) injections of vaccines and other pharmaceutical injectables. The Biojector® 2000 may be used by healthcare providers 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/K121270
Methodology: https://510kreport.com/methodology