Cleared Traditional

K813199 - SKIN TEMPERATURE SENSING VINYL STRIP (FDA 510(k) Clearance)

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

K813199 · T. G. & E. Medical · General Hospital
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Mar 1982
Decision
112d
Days
Class 2
Risk

K813199 is an FDA 510(k) clearance for the SKIN TEMPERATURE SENSING VINYL STRIP. Classified as Strip, Temperature, Forehead, Liquid Crystal (product code KPD), Class II - Special Controls.

Submitted by T. G. & E. Medical (Mchenry, US). The FDA issued a Cleared decision on March 5, 1982 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2200 - 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 K813199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1981
Decision Date March 05, 1982
Days to Decision 112 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
16d faster than avg
Panel avg: 128d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPD Strip, Temperature, Forehead, Liquid Crystal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2200
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.