Cleared Traditional

K082138 - AIRGENT, MODEL AG7000010

K082138 is an FDA 510(k) clearance for AIRGENT, manufactured by Perfaction, Inc.. The device is a Class 2 General Hospital device with product code KZE cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K082138 · Perfaction, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
178d
Days
Class 2
Risk

K082138 is an FDA 510(k) clearance for the AIRGENT, MODEL AG7000010. Classified as Injector, Fluid, Non-electrically Powered (product code KZE), Class II - Special Controls.

Submitted by Perfaction, Inc. (Washington, US). The FDA issued a Cleared decision on January 23, 2009 after a review of 178 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5430 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K082138

510(k) Number K082138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2008
Decision Date January 23, 2009
Days to Decision 178 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 129d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 42
Devices cleared under the same product code (KZE) and FDA review panel - the closest regulatory comparables to K082138.
LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
K090959 · D'Antonio Consultants International, Inc. (Dci) · Dec 2009
ZETAJET
K090003 · Bioject, Inc. · Apr 2009
PHARMAJET NEEDLE-FREE INJECTION SYSTEM
K081532 · Pharmajet, Inc. · Feb 2009
COOL.CLICK 2
K060819 · Medical House Products Limited · Jun 2006
BIOVALVE MINI-JECT NEEDLEFREE INJECTOR
K051985 · Biovalve Technologies, Inc. · Aug 2005
COOL.CLICK
K050734 · Bioject, Inc. · Jun 2005
K082138 · AIRGENT, MODEL AG7000010
Download PDF FDA Summary Perfaction, Inc.