Cleared Traditional

K823245 - THERMAX (FDA 510(k) Clearance)

Also includes:
THERMAX SYSTEM

Class I Radiology device.

K823245 · American Thermometer Company, Inc. · Radiology device
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Nov 1982
Decision
15d
Days
Class 1
Risk

K823245 is an FDA 510(k) clearance for the THERMAX. Classified as System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use) (product code KYA), Class I - General Controls.

Submitted by American Thermometer Company, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1982 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2982 - the FDA radiology and imaging software oversight 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

Submission Details

510(k) Number K823245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1982
Decision Date November 16, 1982
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KYA System, Thermographic, Liquid Crystal, Nonpowered (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2982
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.