Cleared Traditional

K081062 - AIRSONNETT AIRSHOWER AIR 3

K081062 is an FDA 510(k) clearance for AIRSONNETT AIRSHOWER AIR 3, manufactured by Airsonett, Inc.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K081062 · Airsonett, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
207d
Days
Class 2
Risk

K081062 is an FDA 510(k) clearance for the AIRSONNETT AIRSHOWER AIR 3. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Airsonett, Inc. (Findley, US). The FDA issued a Cleared decision on November 7, 2008 after a review of 207 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - 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 - K081062

510(k) Number K081062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date November 07, 2008
Days to Decision 207 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
78d slower than avg
Panel avg: 129d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRF Device Classification - Class 2, Special Controls

Product Code FRF Cleaner, Air, Medical Recirculating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5045
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 - FRF Cleaner, Air, Medical Recirculating

All 46
Devices cleared under the same product code (FRF) and FDA review panel - the closest regulatory comparables to K081062.
Novaerus NV1050
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AIRSONETT AIR-4
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HEPAIRX VENTILATING AIR PURIFIER
K112728 · Air Innovations, Inc. · Jan 2013
AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
K072185 · Airistar Technologies, LLC · Mar 2008
PLASMAIR, MODEL T2006
K070722 · Airinspace B.V. · Dec 2007
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
K023693 · Airex, Inc. · Mar 2003
K081062 · AIRSONNETT AIRSHOWER AIR 3
Download PDF FDA Summary Airsonett, Inc.