510(k) · Cleared
ClearedInfrared Forehead Thermometer, FT-100A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou Universal Electronic Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Aug 24, 2016 as substantially equivalent to K122221 (Taidoc Technology Corporation, 2013) after a 154-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Aug 24, 2016
- Review
- 154 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K061800 (2006). No later device cites it as a predicate yet.
- Root · 4 generations backK061800 Clever TD-1112 Ear/Skin/Surface IR ThermometerTaidoc Technology Corporation · 2006
- 3 generations backK081445 Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261BTaidoc Technology Corporation · 2008
- 2 generations backK113159 U-Right TD-1240 ThermometerTaidoc Technology Corporation · 2012
- 1 generation backK122221 Nexus IR30 Non-Contact Infrared Forehead ThermometerTaidoc Technology Corporation · 2013
- This deviceK160802 Infrared Forehead Thermometer, FT-100AHangzhou Universal Electronic Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K061800 | Clever TD-1112 Ear/Skin/Surface IR Thermometer | Taidoc Technology Corporation | 2006 | — |
| −3 | K081445 | Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B | Taidoc Technology Corporation | 2008 | — |
| −2 | K113159 | U-Right TD-1240 Thermometer | Taidoc Technology Corporation | 2012 | — |
| −1 | K122221 | Nexus IR30 Non-Contact Infrared Forehead Thermometer | Taidoc Technology Corporation | 2013 | — |
| 0 (this device) | K160802 | Infrared Forehead Thermometer, FT-100A | Hangzhou Universal Electronic Co., Ltd. | 2016 | — |
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.
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 10 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K122221.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to be used on forehead to detect body temperature. The FT-100A is intended for home use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160802 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160802: Infrared Forehead Thermometer, FT-100A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160802
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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