510(k) · Cleared
ClearedThermidas IR System (ThIR-A615)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermidas Americas, Inc. · LHQ System, Telethermographic (Adjunctive Use)
Cleared on Jan 6, 2021 as substantially equivalent to K171928 (Med-Hot Thermal Imaging, Inc., 2017) after a 265-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Jan 6, 2021
- Review
- 265 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K063047 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK063047 Medhot Mti 2000 Thermal Imaging SystemMedhot Thermal Imaging, Inc. · 2006 · Recalled
- 1 generation backK171928 Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. · 2017
- This deviceK200999 Thermidas IR System (ThIR-A615)Thermidas Americas, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK253911 Derma-2Neko Health AB · 2026
Most influential descendants
Showing 1 of 1 · See all- K253911Derma-2Neko Health AB · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K063047 | Medhot Mti 2000 Thermal Imaging System | Medhot Thermal Imaging, Inc. | 2006 | 1 |
| −1 | K171928 | Med-Hot Thermal Imaging Systems | Med-Hot Thermal Imaging, Inc. | 2017 | — |
| 0 (this device) | K200999 | Thermidas IR System (ThIR-A615) | Thermidas Americas, Inc. | 2021 | — |
| +1 | K253911 | Derma-2 | Neko Health AB | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LHQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LHQ device
- #1 K253911 Derma-2score 12.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K171928 | Med-Hot Thermal Imaging SystemsSummary page 4…), Class I Reason: New Device Predicate Device Manufacturer: Med-Hot Thermal Imaging, Inc. Trade/Proprietary/Model Name: Med-Hot Thermal Imaging Systems 510(k) Number: K171928 Background The ability to use Infrared technology to measure temperature variations and patterns of the body’s service is commo… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253911 | Derma-2 | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 11.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K253911 (Neko Health AB, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K171928.
How does its category compare?
All LHQ devicesLHQ System, Telethermographic (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LHQ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LHQ
Too few LHQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LHQ
No recall names LHQ since 2007.
Adverse event reports per year · LHQ
1in 2025
MAUDE reports naming product code LHQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging
for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of
temperature patterns and changes. The significance of the value of these thermal patterns is determined by professional
investigation. The system is not intended for absolute temperature measurements. The Thermidas IR system is intended
for use by trained technical personnel.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200999 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200999: Thermidas IR System (ThIR-A615).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200999
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026