510(k) · Cleared
ClearedDT100 Digital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smart Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Sep 26, 2021 as substantially equivalent to K101387 (Fudakang Industries Co., Ltd., 2010) after a 279-day review. Its family tree reaches back 3 generations to 2001. 1 later device descends from it.
- Decided
- Sep 26, 2021
- Review
- 279 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010238 (2001). 1 later device descends 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 deviceK203731 DT100 Digital ThermometerSmart Technology Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK214077 Digital Thermometer, Model: DT007, DT008Guangzhou Berrcom Medical Device Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K214077Digital Thermometer, Model: DT007, DT008Guangzhou Berrcom Medical Device Co., Ltd. · 2023 · cites it directly0descendants
View 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) | K203731 | DT100 Digital Thermometer | Smart Technology Co., Ltd. | 2021 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K101387 | Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNSummary page 5…203731 III. PREDICATE DEVICE Sponsor: Fudakang Industrial Co., Ltd Device Name: Fudakang Digital thermometer; Model: BTA41-CN 510(k) Number: K101387 IV. DEVICE DESCRIPTION DT100 digital thermometer is a fast, highly accurate, and easy to use clinical instru… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K214077 | Digital Thermometer, Model: DT007, DT008 | 2023 | 0 |
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 20 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K214077 (Guangzhou Berrcom Medical Device Co., Ltd., 2023) has gone furthest, with 0 descendants 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. 2021, 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?
DT100 Digital thermometer is intended for the measurement of human body temperature by doctor or consumers in the hospital or home. It can be used for axillary, oral and rectal measurement. The product is reusable and provided non-sterile. The device is for people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203731: DT100 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/K203731
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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