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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K072185.
AIRSONETT AIR-4
K130702 · Airsonett AB · Jul 2013
HEPAIRX VENTILATING AIR PURIFIER
K112728 · Air Innovations, Inc. · Jan 2013
AIRSONNETT AIRSHOWER AIR 3
K081062 · Airsonett, Inc. · Nov 2008
PLASMAIR, MODEL T2006
K070722 · Airinspace B.V. · Dec 2007
MOBILE PARTICULATE CONTAMINATION CONTROL SYSTEM, MODEL M-100
K023693 · Airex, Inc. · Mar 2003
ADVANCED AIR PURIFICATION SYSTEM
K012549 · Healthway Products, Inc. · Feb 2002

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K072185 · AIRISTAR AIR PURIFICATION SYSTEM, MODEL 500 & 1000
Download PDF FDA Summary Airistar Technologies…