Cleared Special

K022148 - INJEX 30 NEEDLE FREE INJECTION SYSTEM

K022148 is an FDA 510(k) clearance for INJEX 30 NEEDLE FREE INJECTION SYSTEM, manufactured by Equidyne Systems, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Special 510(k) pathway after a 21-day FDA review.

K022148 · Equidyne Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
21d
Days
Class 2
Risk

K022148 is an FDA 510(k) clearance for the INJEX 30 NEEDLE FREE INJECTION SYSTEM. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Equidyne Systems, Inc. (San Diego, US). The FDA issued a Cleared decision on July 23, 2002 after a review of 21 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5430 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Equidyne Systems, Inc. devices

FDA 510(k) Submission Details - K022148

510(k) Number K022148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2002
Decision Date July 23, 2002
Days to Decision 21 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

KZE Device Classification - Class 2, Special Controls

Product Code KZE Injector, Fluid, Non-electrically Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5430
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KZE Injector, Fluid, Non-electrically Powered

All 12
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K022148.
BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM
K121270 · Bioject Medical Technologies, Inc. · Jul 2012
PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI
K111517 · Pharmajet, Inc. · Jul 2011
PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM
K110456 · Pharmajet, Inc. · Mar 2011
CLICKER
K994384 · Bioject, Inc. · Jun 2000
MODIFICATION TO MEDI-JECT CORPORATION MEDI-JECTOR CHOICE NEEDLE-FREE INSULIN DELIVERY SYSTEM
K991294 · Medi-Ject Corp. · Apr 1999
J-TIP NEEDLESS INJECTOR
K980082 · National Medical Products, Inc. · Mar 1998