Cleared Traditional

K943238 - NORELCO CLEAN AIR SYSTEM

K943238 is an FDA 510(k) clearance for NORELCO CLEAN AIR SYSTEM, manufactured by Philips Electronic North America Corp. (Pena). The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K943238 · Philips Electronic North America Corp. (Pena) · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
145d
Days
Class 2
Risk

K943238 is an FDA 510(k) clearance for the NORELCO CLEAN AIR SYSTEM. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Philips Electronic North America Corp. (Pena) (Washington, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 145 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 Philips Electronic North America Corp. (Pena) devices

FDA 510(k) Submission Details - K943238

510(k) Number K943238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1994
Decision Date November 28, 1994
Days to Decision 145 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
16d slower than avg
Panel avg: 129d · This submission: 145d
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 K943238.
BREATHE EASY, MODELS AD AND CD
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