Cleared Traditional

K860132 - AIR CARE AIR SANITIZER

K860132 is an FDA 510(k) clearance for AIR CARE AIR SANITIZER, manufactured by Cooper-Hewitt Electric Co.. The device is a Class 2 General Hospital device with product code FRA cleared through the Traditional 510(k) pathway after a 364-day FDA review.

K860132 · Cooper-Hewitt Electric Co. · General Hospital
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Jan 1987
Decision
364d
Days
Class 2
Risk

K860132 is an FDA 510(k) clearance for the AIR CARE AIR SANITIZER. Classified as Purifier, Air, Ultraviolet, Medical (product code FRA), Class II - Special Controls.

Submitted by Cooper-Hewitt Electric Co. (Washington, US). The FDA issued a Cleared decision on January 13, 1987 after a review of 364 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6500 - 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. Elevated predicate reliance profile. 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 Cooper-Hewitt Electric Co. devices

FDA 510(k) Submission Details - K860132

510(k) Number K860132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1986
Decision Date January 13, 1987
Days to Decision 364 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
235d slower than avg
Panel avg: 129d · This submission: 364d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRA Device Classification - Class 2, Special Controls

Product Code FRA Purifier, Air, Ultraviolet, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6500
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 - FRA Purifier, Air, Ultraviolet, Medical

All 26
Devices cleared under the same product code (FRA) and FDA review panel - the closest regulatory comparables to K860132.
MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
K972064 · Biological Controls, Inc. · Dec 1997
VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
K954448 · Schiff & Co. · Oct 1996
VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
K960833 · Uv Technologies, Inc. · Jul 1996