510(k) · Cleared
ClearedCaregiver Professional Clinical Thermometer, Pro-TF Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermomedics, Inc. · FLL Continuous Measurement Thermometer
Cleared on Oct 7, 2013 as substantially equivalent to K113159 (Taidoc Technology Corporation, 2012) after a 112-day review. Its family tree reaches back 3 generations to 2006. 2 later devices descend from it.
- Decided
- Oct 7, 2013
- Review
- 112 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K061800 (2006). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK061800 Clever TD-1112 Ear/Skin/Surface IR ThermometerTaidoc Technology Corporation · 2006
- 2 generations backK081445 Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261BTaidoc Technology Corporation · 2008
- 1 generation backK113159 U-Right TD-1240 ThermometerTaidoc Technology Corporation · 2012
- This deviceK131771 Caregiver Professional Clinical Thermometer, Pro-TF SeriesThermomedics, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK200946 Clever Forehead Thermometer / Clever Medical Forehead Thermometer…Taidoc Technology Corporation · 2022
- Descendant · cites it directly · 0 of its ownK180298 welloStationXWello, Inc. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061800 | Clever TD-1112 Ear/Skin/Surface IR Thermometer | Taidoc Technology Corporation | 2006 | — |
| −2 | K081445 | Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B | Taidoc Technology Corporation | 2008 | — |
| −1 | K113159 | U-Right TD-1240 Thermometer | Taidoc Technology Corporation | 2012 | — |
| 0 (this device) | K131771 | Caregiver Professional Clinical Thermometer, Pro-TF Series | Thermomedics, Inc. | 2013 | — |
| +1 | K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model… | Taidoc Technology Corporation | 2022 | — |
| +1 | K180298 | welloStationX | Wello, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2022 | 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 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? (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 |
|---|---|---|---|
| * | K113159 | U-Right TD-1240 ThermometerSummary page 2…king a temperature measurement. Substantial Equivalence Information: A. Predicate device name: U-RIGHT TD- 1240 Thermometer B. Predicate K number: K 113159 C. Compa~ison with predicate: Caregiver Professional Clinical Thermometer (Model PRO-TF300) has the follo… | 2012 |
What descends from it? (2)
2 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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K200946 (Taidoc Technology Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K113159.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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?
Caregiver professional Clinical Thermometer is an infrared thermometer intended for the
measurement of human body temperature in people of all ages without contact to the
body and may be used by medical professionals or by consumers in a home environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131771: Caregiver Professional Clinical Thermometer, Pro-TF Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131771
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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