510(k) · Cleared
ClearedClever TD-1112 Ear/Skin/Surface IR Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · FLL Continuous Measurement Thermometer
Cleared on Jul 7, 2006 after an 11-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 30 later devices descend from it.
- Decided
- Jul 7, 2006
- Review
- 11 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
30 later devices descend from it, 2 citing it directly.
- This deviceK061800 Clever TD-1112 Ear/Skin/Surface IR ThermometerTaidoc Technology Corporation · 2006
- Descendant · cites it directly · 15 of its ownK083174 HealthepodCard Guard Scientific Survival, Ltd. · 2009
- Descendant · cites it directly · 13 of its ownK081445 Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261BTaidoc Technology Corporation · 2008
- Descendant · 2 generations on · 12 of its ownK093976 Raisin Personal MonitorProteus Biomedical, Inc. · 2010
- Descendant · 2 generations on · 7 of its ownK113159 U-Right TD-1240 ThermometerTaidoc Technology Corporation · 2012
- Descendant · 3 generations on · 6 of its ownK131009 Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013
Showing 5 of 30 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 30 · See all- K083174HealthepodCard Guard Scientific Survival, Ltd. · 2009 · cites it directly15descendants
- K081445Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261BTaidoc Technology Corporation · 2008 · cites it directly13descendants
- K093976Raisin Personal MonitorProteus Biomedical, Inc. · 2010 · 2 generations on12descendants
- K113159U-Right TD-1240 ThermometerTaidoc Technology Corporation · 2012 · 2 generations on7descendants
- K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061800 | Clever TD-1112 Ear/Skin/Surface IR Thermometer | Taidoc Technology Corporation | 2006 | — |
| +1 | K083174 | Healthepod | Card Guard Scientific Survival, Ltd. | 2009 | — |
| +1 | K081445 | Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B | Taidoc Technology Corporation | 2008 | — |
| +2 | K093976 | Raisin Personal Monitor | Proteus Biomedical, Inc. | 2010 | — |
| +2 | K113159 | U-Right TD-1240 Thermometer | Taidoc Technology Corporation | 2012 | — |
| +3 | K131009 | Proteus Patch, Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLL? 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 FLL device
- #1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (30)
See all 302 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K083174 (Card Guard Scientific Survival, Ltd., 2009) has gone furthest, with 15 descendants of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLL
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLL
73in 2025
MAUDE reports naming product code FLL, 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 | 15 | 81 | 0 | 4 |
| 2008 | 14 | 59 | 0 | 13 |
| 2009 | 13 | 84 | 0 | 9 |
| 2010 | 24 | 88 | 0 | 9 |
| 2011 | 20 | 113 | 1 | 18 |
| 2012 | 17 | 126 | 0 | 26 |
| 2013 | 14 | 149 | 0 | 16 |
| 2014 | 7 | 199 | 0 | 54 |
| 2015 | 3 | 270 | 1 | 53 |
| 2016 | 22 | 157 | 0 | 58 |
| 2017 | 16 | 174 | 2 | 118 |
| 2018 | 35 | 209 | 1 | 51 |
| 2019 | 22 | 198 | 5 | 52 |
| 2020 | 21 | 194 | 0 | 53 |
| 2021 | 43 | 218 | 0 | 115 |
| 2022 | 24 | 218 | 0 | 142 |
| 2023 | 17 | 295 | 0 | 101 |
| 2024 | 13 | 223 | 0 | 118 |
| 2025 | 6 | 131 | 1 | 73 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Clever TD-1112 ear/skin/surface IR thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the ear canal on people of all ages and for use in the home. It is also available to detect object's surface temperature including human skin.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K061800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061800: Clever TD-1112 Ear/Skin/Surface IR Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061800
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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