510(k) · Cleared
ClearedDigital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fudakang Industrial Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jun 7, 2018 as substantially equivalent to K160308 (Fudakang Industrial Co., Ltd., 2016) and 1 other predicate after a 329-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jun 7, 2018
- Review
- 329 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K010238 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK010238 Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010…Actherm, Inc. · 2001
- 4 generations backK072641 Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Famidoc Technology Co., Ltd. · 2007
- 3 generations backK101387 Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNFudakang Industries Co., Ltd. · 2010
- 2 generations backK132514 Kinsa Smart ThermometerKinsa, Inc. · 2013
- 1 generation backK152739 Electronic ThermometerGuangdong Biolight Meditech Co., Ltd. · 2016
- This deviceK172121 Digital ThermometerFudakang Industrial Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010238 | Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+… | Actherm, Inc. | 2001 | — |
| −4 | K072641 | Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4. | Famidoc Technology Co., Ltd. | 2007 | — |
| −3 | K101387 | Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN | Fudakang Industries Co., Ltd. | 2010 | — |
| −2 | K132514 | Kinsa Smart Thermometer | Kinsa, Inc. | 2013 | — |
| −1 | K152739 | Electronic Thermometer | Guangdong Biolight Meditech Co., Ltd. | 2016 | — |
| 0 (this device) | K172121 | Digital Thermometer | Fudakang Industrial Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (2)
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 |
|---|---|---|---|
| * | K160308 | Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)Summary page 4…910 3. Legally Marketed Predicate Device Trade Name Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) 510(k) Number K160308 Product Code FLL Manufacturer Fudakang Industrial Co., Ltd. Trade Name… | 2016 |
| * | K152739 | Electronic ThermometerSummary page 4…Manufacturer Fudakang Industrial Co., Ltd. Trade Name Electronic Thermometer, Model WT1 and WT2 510(k) Number K152739 Product Code FLL Page 1 / 5 Fudakang Industr… | 2016 |
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 17 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Digital thermometers (Model: TP-100, TP-200, TP-300, TP-400, TP-500, BT-A31A-BT) is intended for the measurement and monitoring of oral or axillary for adult , pediatric and infant temperature via thermistor by doctor or consumers in the hospital or home. The result of measurement and monitoring will be transmitted via Bluetooth (BLE) to Bluetooth enabled smart mobile device (cell phone, iPad) with GuardiAngel App installed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172121 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172121: Digital Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172121
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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