Cleared Traditional

K771980 - FEVER TESTER

K771980 is an FDA 510(k) clearance for FEVER TESTER, manufactured by American Thermometer Company, Inc.. The device is a Class 2 General Hospital device with product code KPD cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K771980 · American Thermometer Company, Inc. · General Hospital
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Nov 1977
Decision
16d
Days
Class 2
Risk

K771980 is an FDA 510(k) clearance for the FEVER TESTER. Classified as Strip, Temperature, Forehead, Liquid Crystal (product code KPD), Class II - Special Controls.

Submitted by American Thermometer Company, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1977 after a review of 16 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Thermometer Company, Inc. devices

FDA 510(k) Submission Details - K771980

510(k) Number K771980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1977
Decision Date November 02, 1977
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPD Device Classification - Class 2, Special Controls

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.