Cleared Traditional

K070722 - PLASMAIR, MODEL T2006

K070722 is an FDA 510(k) clearance for PLASMAIR, manufactured by Airinspace B.V.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 274-day FDA review.

K070722 · Airinspace B.V. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
274d
Days
Class 2
Risk

K070722 is an FDA 510(k) clearance for the PLASMAIR, MODEL T2006. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Airinspace B.V. (Leesburg, US). The FDA issued a Cleared decision on December 14, 2007 after a review of 274 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 - K070722

510(k) Number K070722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2007
Decision Date December 14, 2007
Days to Decision 274 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
145d slower than avg
Panel avg: 129d · This submission: 274d
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 K070722.
HEPAIRX VENTILATING AIR PURIFIER
K112728 · Air Innovations, Inc. · Jan 2013
AIRSONNETT AIRSHOWER AIR 3
K081062 · Airsonett, Inc. · Nov 2008
AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
K072185 · Airistar Technologies, LLC · Mar 2008
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
K023693 · Airex, Inc. · Mar 2003
ADVANCED AIR PURIFICATION SYSTEM
K012549 · Healthway Products, Inc. · Feb 2002
DEFENDER ROOM AIR CLEANER, MODEL RAC-4000A
K010616 · Hmi Industries, Inc. · Mar 2001
K070722 · PLASMAIR, MODEL T2006
Download PDF FDA Summary Airinspace B.V.