Cleared Traditional

K942512 - PA300

K942512 is an FDA 510(k) clearance for PA300, manufactured by The Rival Co.. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K942512 · The Rival Co. · General Hospital
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Nov 1994
Decision
176d
Days
Class 2
Risk

K942512 is an FDA 510(k) clearance for the PA300. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by The Rival Co. (Clinton, US). The FDA issued a Cleared decision on November 18, 1994 after a review of 176 days - an extended review 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: 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 The Rival Co. devices

FDA 510(k) Submission Details - K942512

510(k) Number K942512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1994
Decision Date November 18, 1994
Days to Decision 176 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
47d slower than avg
Panel avg: 129d · This submission: 176d
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 K942512.
MICROCON 800M, MICROCON 400M, MICROCON EXC, MICROCON EX, MICROCON WALLMAP
K974682 · Biological Controls, Inc. · Jan 1998
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NORELCO CLEAN AIR SYSTEM CAS950
K945161 · Hogan & Hartson · Nov 1994
FILTER, PARTICULATE ARRESTING
K760481 · Miles Laboratories, Inc. · Sep 1976