Cleared Traditional

K944927 - NORELCO CLEAN AIR SYSTEM CAS900

K944927 is an FDA 510(k) clearance for NORELCO CLEAN AIR SYSTEM CAS900, 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 53-day FDA review.

K944927 · Norelco Consumer Products Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
53d
Days
Class 2
Risk

K944927 is an FDA 510(k) clearance for the NORELCO CLEAN AIR SYSTEM CAS900. 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 November 28, 1994 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Norelco Consumer Products Co. devices

FDA 510(k) Submission Details - K944927

510(k) Number K944927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1994
Decision Date November 28, 1994
Days to Decision 53 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 129d · This submission: 53d
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 K944927.
BREATHE EASY, MODELS AD AND CD
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NORELCO CLEAN AIR SYSTEM CAS950
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