Cleared Traditional

K072185 - AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000

K072185 is an FDA 510(k) clearance for AIRISTAR AIR PURIFICATION SYSTEM, manufactured by Airistar Technologies, LLC. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K072185 · Airistar Technologies, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
234d
Days
Class 2
Risk

K072185 is an FDA 510(k) clearance for the AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Airistar Technologies, LLC (Deer Field, US). The FDA issued a Cleared decision on March 27, 2008 after a review of 234 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.

View all Airistar Technologies, LLC devices

FDA 510(k) Submission Details - K072185

510(k) Number K072185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2007
Decision Date March 27, 2008
Days to Decision 234 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 129d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 14
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