510(k) · Cleared
ClearedDigital Thermometer, Model: DT007, DT008
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Berrcom Medical Device Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jan 20, 2023 as substantially equivalent to K203731 (Smart Technology Co., Ltd., 2021) after a 389-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Jan 20, 2023
- Review
- 389 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010238 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK010238 Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010…Actherm, Inc. · 2001
- 3 generations backK072641 Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4.Famidoc Technology Co., Ltd. · 2007
- 2 generations backK101387 Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CNFudakang Industries Co., Ltd. · 2010
- 1 generation backK203731 DT100 Digital ThermometerSmart Technology Co., Ltd. · 2021
- This deviceK214077 Digital Thermometer, Model: DT007, DT008Guangzhou Berrcom Medical Device Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010238 | Actherm Digital Clinical Thermometer, Models ACT2000, ACT2010, ACT2000+… | Actherm, Inc. | 2001 | — |
| −3 | K072641 | Digital Electronic Thermometer, Model: FDTH-V0-1 Thru 4. | Famidoc Technology Co., Ltd. | 2007 | — |
| −2 | K101387 | Digital Thermometer, Models BT-A11CN, BT-A21CN, BT-A41CN | Fudakang Industries Co., Ltd. | 2010 | — |
| −1 | K203731 | DT100 Digital Thermometer | Smart Technology Co., Ltd. | 2021 | — |
| 0 (this device) | K214077 | Digital Thermometer, Model: DT007, DT008 | Guangzhou Berrcom Medical Device Co., Ltd. | 2023 | — |
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 |
|---|---|---|---|
| * | K203731 | DT100 Digital ThermometerSummary page 4…Manufacturer: Smart Technology Co., Ltd. Device Name: Digital Thermometer Model: DT100 510(k) Number: K203731 Product Code: FLL 4. Device Description The basic principle of Digital Thermometer is that a change in thermistor… | 2021 |
| † | K163603 | Digital Thermometer | 2017 |
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 22 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- None of the 4 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. 2023, 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?
DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people…
Read the full statement (152 words)
DT007 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
DT008 Digital Thermometer is intended for the measurement of human body temperature by doctors or customers in the hospital or at home. It can be used for axillary, oral temperature measurement at home, and used for axillary, oral and rectal temperature measurement in the hospital. The rectal body temperature measurement cannot be used for multi-patient use at home. The product is reusable and provided nonsterile. The device is intended for use on people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214077 · printed Nov 6, 2026
Cite this page
510(k) Report. “K214077: Digital Thermometer, Model: DT007, DT008.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214077
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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