Cleared Traditional

K802228 - BIOLOGICAL INDICATOR - KEMMED & BIOSURE

K802228 is the FDA 510(k) clearance for BIOLOGICAL INDICATOR - KEMMED & BIOSURE by Kem Medical Products Corp.. It is a Class 2 General Hospital device (product code FRC) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K802228 · Kem Medical Products Corp. · General Hospital
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Dec 1980
Decision
90d
Days
Class 2
Risk

K802228 is an FDA 510(k) clearance for the BIOLOGICAL INDICATOR - KEMMED & BIOSURE. Classified as Indicator, Biological Sterilization Process (product code FRC), Class II - Special Controls.

Submitted by Kem Medical Products Corp. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1980 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2800 - 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.

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Submission Details

510(k) Number K802228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1980
Decision Date December 09, 1980
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRC Indicator, Biological Sterilization Process
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2800
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.