Cleared Traditional

K792633 - STERILIZATION PROCESS/OUTERWRAP (FDA 510(k) Clearance)

Class I Pathology device.

K792633 · Procter & Gamble Mfg. Co. · Pathology device
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Jan 1980
Decision
23d
Days
Class 1
Risk

K792633 is an FDA 510(k) clearance for the STERILIZATION PROCESS/OUTERWRAP. Classified as Filters, Cell Collection, Tissue Processing (product code KET), Class I - General Controls.

Submitted by Procter & Gamble Mfg. Co. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3010 - the FDA pathology 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 Procter & Gamble Mfg. Co. devices

Submission Details

510(k) Number K792633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1979
Decision Date January 11, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 77d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KET Filters, Cell Collection, Tissue Processing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3010
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.