510(k) · Cleared
ClearedDerma-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neko Health AB · LHQ System, Telethermographic (Adjunctive Use)
Cleared on May 20, 2026 as substantially equivalent to K200999 (Thermidas Americas, Inc., 2021) after a 163-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- May 20, 2026
- Review
- 163 days
- Class
- Class I
- Product code
- LHQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K063047 (2006). No later device cites it as a predicate yet.
- Root · 3 generations backK063047 Medhot Mti 2000 Thermal Imaging SystemMedhot Thermal Imaging, Inc. · 2006 · Recalled
- 2 generations backK171928 Med-Hot Thermal Imaging SystemsMed-Hot Thermal Imaging, Inc. · 2017
- 1 generation backK200999 Thermidas IR System (ThIR-A615)Thermidas Americas, Inc. · 2021
- This deviceK253911 Derma-2Neko Health AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K063047 | Medhot Mti 2000 Thermal Imaging System | Medhot Thermal Imaging, Inc. | 2006 | 1 |
| −2 | K171928 | Med-Hot Thermal Imaging Systems | Med-Hot Thermal Imaging, Inc. | 2017 | — |
| −1 | K200999 | Thermidas IR System (ThIR-A615) | Thermidas Americas, Inc. | 2021 | — |
| 0 (this device) | K253911 | Derma-2 | Neko Health AB | 2026 | — |
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 K232462 ThermPix Thermovisual Camerascore 6.9 · 4 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 |
|---|---|---|---|
| * | K200999 | Thermidas IR System (ThIR-A615)Summary page 6…edicate Device 1.3.1 Thermidas IR System (ThIR-A615) The primary predicate device for the Derma-2 is the Thermidas IR System (ThIR-A615) cleared under K200999. 510(k) Number K200999 Trade Name: Thermidas IR System (ThIR-A615) Common Name:… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 20 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All LHQ devicesLHQ System, Telethermographic (Adjunctive Use): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Derma-2 device is intended for adjunctive use in addition to other clinical methods and procedures for visually and thermally significant indications of an individual’s skin. The Derma-2 device is intended for displaying, reviewing, and reporting of images of the skin as well as temperature patterns and changes. The significance of these images and thermal patterns is determined by professional investigation. The Derma-2 device is not intended for…
Read the full statement (122 words)
The Derma-2 device is intended for adjunctive use in addition to other clinical methods and procedures for visually and thermally significant indications of an individual’s skin.
The Derma-2 device is intended for displaying, reviewing, and reporting of images of the skin as well as temperature patterns and changes. The significance of these images and thermal patterns is determined by professional investigation.
The Derma-2 device is not intended for absolute temperature measurements. The system is not intended to be used as a thermometry device. The Derma-2 device is intended for use by trained personnel.
The Derma-2 system provides relative surface temperature information only. The device does not identify anatomical structures. Interpretation of thermal patterns remains solely the responsibility of the qualified healthcare professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253911: Derma-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253911
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026