Cleared Traditional

K802229 - CHEMICAL INDICATOR - KEM MED & BIO SURE

K802229 is an FDA 510(k) clearance for CHEMICAL INDICATOR - KEM MED & BIO SURE, manufactured by Kem Medical Products Corp.. The device is a Class 2 General Hospital device with product code JOJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K802229 · Kem Medical Products Corp. · General Hospital
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Dec 1980
Decision
90d
Days
Class 2
Risk

K802229 is an FDA 510(k) clearance for the CHEMICAL INDICATOR - KEM MED & BIO SURE. Classified as Indicator, Physical/chemical Sterilization Process (product code JOJ), 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 - K802229

510(k) Number K802229 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.

JOJ Device Classification - Class 2, Special Controls

Product Code JOJ Indicator, Physical/chemical 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 - JOJ Indicator, Physical/chemical Sterilization Process

All 218
Devices cleared under the same product code (JOJ) and FDA review panel - the closest regulatory comparables to K802229.
CHEMICAL AUTOCLAVE INDICATOR TAPE
K811936 · American Hospital Supply Corp. · Jul 1981
CASTLE STEAM STERILIZATION INDICATOR
K810614 · Sybron Corp. · Jun 1981
STERIGAGE EO ETHYL. OXIDE STERIL. INDIC.
K802634 · Organon, Inc. · Dec 1980
CHEMDI
K801428 · American Sterilizer Co. · Aug 1980
3M STEAM STERILIZATION INDICATOR
K801057 · 3M Company · Jun 1980
PROOF (BIOLOGICAL/CHEMICAL INDICATOR)
K801109 · Amsco Co. · May 1980