510(k) · Cleared
ClearedKinsa Smart Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinsa, Inc. · FLL Continuous Measurement Thermometer
Cleared on Dec 2, 2013 as substantially equivalent to K101387 (Fudakang Industries Co., Ltd., 2010) after a 112-day review. Its family tree reaches back 3 generations to 2001. 2 later devices descend from it.
- Decided
- Dec 2, 2013
- Review
- 112 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010238 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010238 Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010…Actherm, Inc. · 2001
- 2 generations backK072641 Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Famidoc Technology Co., Ltd. · 2007
- 1 generation backK101387 Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNFudakang Industries Co., Ltd. · 2010
- This deviceK132514 Kinsa Smart ThermometerKinsa, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK152739 Electronic ThermometerGuangdong Biolight Meditech Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK172121 Digital ThermometerFudakang Industrial Co., Ltd. · 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 | K010238 | Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+… | Actherm, Inc. | 2001 | — |
| −2 | K072641 | Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4. | Famidoc Technology Co., Ltd. | 2007 | — |
| −1 | K101387 | Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN | Fudakang Industries Co., Ltd. | 2010 | — |
| 0 (this device) | K132514 | Kinsa Smart Thermometer | Kinsa, Inc. | 2013 | — |
| +1 | K152739 | Electronic Thermometer | Guangdong Biolight Meditech Co., Ltd. | 2016 | — |
| +2 | K172121 | Digital Thermometer | Fudakang Industrial Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K101387 | Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNSummary page 2…te Device Feature Fudakang Digital Kinsa Smart Thermometer Thermometer (K(101387) (KXXXXXX) Intended Use Measurement and monitoring of… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152739 | Electronic Thermometer | 2016 | 1 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K152739 (Guangdong Biolight Meditech Co., Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K101387.
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?
The Kinso Smart Thermometer is intended to measure the human body temperature orally, rectally, or under the arm, and the devices are reusable for clinical or home use on people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132514: Kinsa Smart Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132514
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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