Cleared Traditional

K200999 - Thermidas IR System (ThIR-A615)

K200999 is an FDA 510(k) clearance for Thermidas IR System (ThIR-A615), manufactured by Thermidas Americas, Inc.. The device is a Class 1 Radiology device with product code LHQ cleared through the Traditional 510(k) pathway after a 265-day FDA review.

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

FDA 510(k) Submission Details - K200999

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.

LHQ Device Classification - Class 1, General Controls

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.