Cleared Traditional

K200999 - Thermidas IR System (ThIR-A615) (FDA 510(k) Clearance)

Class I Radiology device.

K200999 · Thermidas Americas, Inc. · Radiology device
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Jan 2021
Decision
265d
Days
Class 1
Risk

K200999 is an FDA 510(k) clearance for the Thermidas IR System (ThIR-A615). Classified as System, Telethermographic (adjunctive Use) (product code LHQ), Class I - General Controls.

Submitted by Thermidas Americas, Inc. (South Pasadena, US). The FDA issued a Cleared decision on January 6, 2021 after a review of 265 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2980 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Thermidas Americas, Inc. devices

Submission Details

510(k) Number K200999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2020
Decision Date January 06, 2021
Days to Decision 265 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
158d slower than avg
Panel avg: 107d · This submission: 265d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LHQ System, Telethermographic (adjunctive Use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.2980
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.

Regulatory Consultant

Gunster, Yoakley & Stewart, P.A.
Samantha L Prokop

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.