Cleared Traditional

K942686 - NORELCO CLEAN AIR SYSTEM MODEL CAM665

K942686 is an FDA 510(k) clearance for NORELCO CLEAN AIR SYSTEM MODEL CAM665, manufactured by Norelco Consumer Products Co.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K942686 · Norelco Consumer Products Co. · General Hospital
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Oct 1994
Decision
122d
Days
Class 2
Risk

K942686 is an FDA 510(k) clearance for the NORELCO CLEAN AIR SYSTEM MODEL CAM665. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Norelco Consumer Products Co. (Washington, US). The FDA issued a Cleared decision on October 7, 1994 after a review of 122 days - within the typical 510(k) review window.

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 Norelco Consumer Products Co. devices

FDA 510(k) Submission Details - K942686

510(k) Number K942686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date October 07, 1994
Days to Decision 122 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 129d · This submission: 122d
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 20
Devices cleared under the same product code (FRF) and FDA review panel - the closest regulatory comparables to K942686.
MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
K974682 · Biological Controls, Inc. · Jan 1998
HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588
K960966 · Sunbeam-Oster Household Products · Jan 1997
NORELCO CLEAN AIR SYSTEM CAS950
K945161 · Hogan & Hartson · Nov 1994
FILTER, PARTICULATE ARRESTING
K760481 · Miles Laboratories, Inc. · Sep 1976