Cleared Traditional

K802228 - BIOLOGICAL INDICATOR - KEMMED & BIOSURE

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

K802228 · Kem Medical Products Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Kem Medical Products Corp. devices

FDA 510(k) Submission Details - K802228

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.

FRC Device Classification - Class 2, Special Controls

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.

Regulatory Peers - FRC Indicator, Biological Sterilization Process

All 181
Devices cleared under the same product code (FRC) and FDA review panel - the closest regulatory comparables to K802228.
TRAVASPORE BIOLOGICAL INDICATOR
K832922 · Travenol Laboratories, S.A. · Nov 1983
CASTLE TEC-TEST BIOLOGICAL INDICATOR
K812272 · Sybron Corp. · Sep 1981
BACILLUM PUMILUS SPORE STRIPS
K810930 · Oxoid U.S.A., Inc. · Jun 1981
STEAROTHERMOHILUS SPORE STRIPS
K800482 · Mdt Corp., Inc. · Apr 1980
SURGICOT 2 INDICATOR SYSTEM
K800029 · Surgicot, Inc. · Mar 1980
UNILAB CULTURING SET
K792648 · Sybron Corp. · Feb 1980