510(k) · Cleared
ClearedWireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rio Flexon Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Mar 18, 2010 as substantially equivalent to K081256 (Rio Flexon Technology Co., Ltd., 2008) after a 52-day review. Its family tree reaches back 5 generations to 2001. 37 later devices descend from it.
- Decided
- Mar 18, 2010
- Review
- 52 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010462 (2001). 7 ancestors in all, the oldest K003326 (2001). 37 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 4 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 3 generations backK050463 Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110…Taidoc Technology Corporation · 2005
- 2 generations backK062445 Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007
- 1 generation backK081256 Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008
- This deviceK100226 Wireless Body Temperature Monitor Model BTM-Dix Series…Rio Flexon Technology Co., Ltd. · 2010
- Descendant · cites it directly · 36 of its ownK121696 Wireless ThermometerRaling Medical Company · 2012
- Descendant · 2 generations on · 35 of its ownK132761 Wireless ThermometerRaiing Medical Company · 2014
- Descendant · 3 generations on · 27 of its ownK160306 Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. · 2016
- Descendant · 4 generations on · 26 of its ownK181013 Fever ScoutVivaLNK, Inc. · 2018
- Descendant · 5 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K121696Wireless ThermometerRaling Medical Company · 2012 · cites it directly36descendants
- K132761Wireless ThermometerRaiing Medical Company · 2014 · 2 generations on35descendants
- K160306Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. · 2016 · 3 generations on27descendants
- K181013Fever ScoutVivaLNK, Inc. · 2018 · 4 generations on26descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −4 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −3 | K050463 | Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110… | Taidoc Technology Corporation | 2005 | — |
| −2 | K062445 | Monitoring Ear Thermometer, Model BTM-D1A | Rio Flexon Technology Co., Ltd. | 2007 | — |
| −1 | K081256 | Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H | Rio Flexon Technology Co., Ltd. | 2008 | — |
| 0 (this device) | K100226 | Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) | Rio Flexon Technology Co., Ltd. | 2010 | — |
| +1 | K121696 | Wireless Thermometer | Raling Medical Company | 2012 | — |
| +2 | K132761 | Wireless Thermometer | Raiing Medical Company | 2014 | — |
| +3 | K160306 | Cloud Smart Thermometer | Guangzhou Bosma Technology Co, Ltd. | 2016 | — |
| +4 | K181013 | Fever Scout | VivaLNK, Inc. | 2018 | — |
| +5 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K081256 | Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HSummary page 2…cording to the US standard ASTM El 112-00 and ASTM E1965-02. Comparison to Predicate Devices: The new BTM-D1X series is the same as the predicate BTM-DIX series under K081256, except for the addition of the high/low alarm function. Prior BTM-… | 2008 |
| † | K050463 | Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110 Ear/Skin/Surface IR… | 2005 |
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121696 | Wireless Thermometer | 2012 | 36 |
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 9 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K121696 (Raling Medical Company, 2012) has gone furthest, with 36 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. 2010, 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 Wireless Body Temperature Monitor, model BIM-DIX series (model BTM-D1IC, D, E, F, O and H), is a battery-operated electronic device with intended use of measuring human ear temperature precisely and continuously monitoring armpit temperature via wireless signal transmission of the measuring result. This device is reusable and is intended for ear temperature measurement as well as armpit temperature monitoring for persons over two years old. Model BTM-D1C has two functions, both ear temperature measurement and armpit temperature monitoring. The rest of models, BTM-D1D, E, F, U and H, have only the function of armpit temperature monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100226: Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100226
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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