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Pharmajet Needle-Free Injection System

by Pharmajet, Inc.

510(k) K081532

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081532 Date26 Feb 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KZE
Device Class
Class II
Regulation
21 CFR Part 880.5430
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pharmajet Needle-Free Injection System is a Needle-Free Injector, Fluid, Non-Electrically Powered (per FDA classification KZE). It delivers medication via a high-velocity fluid jet that penetrates the skin without a traditional needle, enabling precise subcutaneous dosing. Designed for rapid administration—within one-tenth of a second—the system ensures accurate depth and volume delivery, reducing patient discomfort and risk of needle-related injuries. Its mechanism relies on spring-powered propulsion to generate a controlled fluid stream, eliminating the need for sharp instruments while maintaining efficacy for pharmaceutical formulations including peptides, hormones, and small molecules.

This system is intended for use in general hospital settings and is supplied as a single-use or reusable device, depending on the model variant. Sterility and regulatory compliance are ensured through FDA clearance under 510(k) K081532, classified as a Class II medical device. Models vary in fluid capacity and injection parameters, with some configurations optimized for self-administration or home use. Storage and handling follow standard aseptic protocols to maintain device integrity, and MRI safety is confirmed as non-interfering. Authorized variants are tracked via registration numbers (e.g., 3002939152) under FDA regulation 880.5430.

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