Cleared Traditional

K802229 - CHEMICAL INDICATOR - KEM MED & BIO SURE (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802229 · Kem Medical Products Corp. · General Hospital
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.

Submission Details

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 -
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 169d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
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