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Injex Needle-Free Injection System; Rojex Needle-Free Injection System

by Rosch AG Medizintechnic

510(k) K020786

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 NumberK020786 Date25 Sep 2002ClearedStatusActive

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  • Withdrawn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
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 880.5430
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Injex Needle-Free Injection System; Rojex Needle-Free Injection System is a needle-free injection system that delivers liquid medication subcutaneously using high-velocity fluid jets. It is classified as a Fluid, Non-Electrically Powered Injector under FDA device class 2, with product code KZE and regulation number 880.5430. The system is substantially equivalent to a predicate device and was cleared via a traditional 510(k) pathway (K020786) on September 25, 2002.

The Injex variant is a multi-use device requiring a reset box to tension an internal spring, while the Rojex variant is a single-use, pre-tensed disposable device. Both are intended for use in general hospital settings. The device is supplied as a spring-driven injector capable of producing a fine, cone-shaped, spray-like drug pattern through a microscopic orifice for subcutaneous delivery of various drugs and injectables.