510(k) · Cleared
ClearedMedical electronic thermometer (FC01, FC02)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhuzhou Goldenhot Medical Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Apr 12, 2024 as substantially equivalent to K223044 (Shen Zhen Rong Feng Technology Co., Ltd., 2023) after an 87-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Apr 12, 2024
- Review
- 87 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K902624 (1990). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK902624 BD Flexible Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 7 generations backK062784 Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403…Sejoy Electronics & Instruments Co., Ltd. · 2007
- 6 generations backK110776 Digital Thermometer MT SeriesSejoy Electronics & Instruments Co., Ltd. · 2011
- 5 generations backK153149 Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132…Sejoy Electronics & Instruments Co., Ltd. · 2016
- 4 generations backK163518 Digital ThermometerJoytech Healthcare Co., Ltd. · 2017
- 3 generations backK183393 Digital ThermometerJoytech Healthcare Co., Ltd. · 2019
- 2 generations backK200599 Digital ThermometerJoytech Healthcare Co., Ltd. · 2020
- 1 generation backK223044 Digital Thermometer (Model QT001)Shen Zhen Rong Feng Technology Co., Ltd. · 2023
- This deviceK240109 Medical electronic thermometer (FC01, FC02)Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K902624 | BD Flexible Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −7 | K062784 | Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403 and MT-405) | Sejoy Electronics & Instruments Co., Ltd. | 2007 | — |
| −6 | K110776 | Digital Thermometer MT Series | Sejoy Electronics & Instruments Co., Ltd. | 2011 | — |
| −5 | K153149 | Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333… | Sejoy Electronics & Instruments Co., Ltd. | 2016 | — |
| −4 | K163518 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2017 | — |
| −3 | K183393 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2019 | — |
| −2 | K200599 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2020 | — |
| −1 | K223044 | Digital Thermometer (Model QT001) | Shen Zhen Rong Feng Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K223044 | Digital Thermometer (Model QT001)Summary page 4…Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Regulation Number: 21 CFR 880.2910 IV. Predicate Device 510(k) Number: K223044 Trade Name: Digital Thermometer (Model QT001) Common or Usual Name: Thermometer, electronic, clinical Regulation N… | 2023 |
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 34 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 11 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. 2024, 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 Medical Electronic Thermometer (FC01, FC02) is intended to measure the human body temperature under the arm.
The devices are reusable for clinical or home use for people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240109: Medical electronic thermometer (FC01, FC02).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240109
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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