# K110456: Pharmajet 0.1 ML Intradermal Needle-Free Injection System

- Pathway: 510(k) (Traditional)
- Applicant: Pharmajet, Inc.
- Decided: Mar 2, 2011 after 14 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: 3 generations back to K920631 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081532: Pharmajet Needle-Free Injection System, Pharmajet, Inc. (2009) Summary page 2.
- K980796: Terumo Allergy Syringe, Terumo Corp. (1998) Summary page 2.

## Most influential descendants
- K121270: Bioject Needle-Free Injection Management System (2012), 0 descendants of its own

## Indications for use
The PharmaJet Needle-free Injection System is intended to deliver various medications and vaccines intradermally by means of a narrow, high velocity fluid jet, which penetrates the skin and delivers the medicine or vaccine into the dermis. Healthcare providers who routinely administer injections may use the PharmaJet Needle-free Injection System. It 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/K110456
Methodology: https://510kreport.com/methodology