510(k) · Cleared
ClearedDigital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fudakang Industries Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Aug 3, 2010 as substantially equivalent to K072641 (Famidoc Technology Co., Ltd., 2007) after a 77-day review. Its family tree reaches back 2 generations to 2001. 8 later devices descend from it.
- Decided
- Aug 3, 2010
- Review
- 77 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010238 (2001). 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK010238 Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010…Actherm, Inc. · 2001
- 1 generation backK072641 Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Famidoc Technology Co., Ltd. · 2007
- This deviceK101387 Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNFudakang Industries Co., Ltd. · 2010
- Descendant · cites it directly · 2 of its ownK132514 Kinsa Smart ThermometerKinsa, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK203731 DT100 Digital ThermometerSmart Technology Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK190990 Digital ThermometerXiamen Ants Bro Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK152739 Electronic ThermometerGuangdong Biolight Meditech Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK214077 Digital Thermometer, Model: DT007, DT008Guangzhou Berrcom Medical Device Co., Ltd. · 2023
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K132514Kinsa Smart ThermometerKinsa, Inc. · 2013 · cites it directly2descendants
- K203731DT100 Digital ThermometerSmart Technology Co., Ltd. · 2021 · cites it directly1descendant
- K190990Digital ThermometerXiamen Ants Bro Technology Co., Ltd. · 2019 · cites it directly1descendant
- K152739Electronic ThermometerGuangdong Biolight Meditech Co., Ltd. · 2016 · 2 generations on1descendant
- K214077Digital Thermometer, Model: DT007, DT008Guangzhou Berrcom Medical Device Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010238 | Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+… | Actherm, Inc. | 2001 | — |
| −1 | K072641 | Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4. | Famidoc Technology Co., Ltd. | 2007 | — |
| 0 (this device) | K101387 | Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN | Fudakang Industries Co., Ltd. | 2010 | — |
| +1 | K132514 | Kinsa Smart Thermometer | Kinsa, Inc. | 2013 | — |
| +1 | K203731 | DT100 Digital Thermometer | Smart Technology Co., Ltd. | 2021 | — |
| +1 | K190990 | Digital Thermometer | Xiamen Ants Bro Technology Co., Ltd. | 2019 | — |
| +2 | K152739 | Electronic Thermometer | Guangdong Biolight Meditech Co., Ltd. | 2016 | — |
| +2 | K214077 | Digital Thermometer, Model: DT007, DT008 | Guangzhou Berrcom Medical Device Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K072641 | Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Summary page 2…Device: Farniidoc Digital Clinical Thermometer FDTH-VO-l, FDTH-VO-2, FDTH-VO-3, FDTH-VO-4. 5 10(K) Number: K072641 4.0 Device description Fudakang digital ther~rnmeters are hand-held, reusable, battery operated. The models in… | 2007 |
What descends from it? (8)
4 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 9 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132514 (Kinsa, Inc., 2013) has gone furthest, with 2 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?
Fudakang Digital Thermometers are intended for the measurement and monitoring of human body temperature by doctor or consumers in the hospital or home.
BT-Al 1CN, BT-A21CN, BT-A41CN can be used for axillary measurement, oral measurement and rectal measurement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101387: Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101387
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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