Cleared Traditional

K945161 - NORELCO CLEAN AIR SYSTEM CAS950 (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K945161 · Hogan & Hartson · General Hospital
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Optimized for regulatory review, auditing and printing
Nov 1994
Decision
42d
Days
Class 2
Risk

K945161 is an FDA 510(k) clearance for the NORELCO CLEAN AIR SYSTEM CAS950. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on November 28, 1994 after a review of 42 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 Hogan & Hartson devices

Submission Details

510(k) Number K945161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1994
Decision Date November 28, 1994
Days to Decision 42 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
86d faster than avg
Panel avg: 128d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 52
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