510(k) · Cleared
ClearedDigital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sejoy Electronics & Instruments Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on May 27, 2016 as substantially equivalent to K110776 (Sejoy Electronics & Instruments Co., Ltd., 2011) after a 210-day review. Its family tree reaches back 3 generations to 1990. 7 later devices descend from it.
- Decided
- May 27, 2016
- Review
- 210 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902624 (1990). 6 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK902624 BD Flexible Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 2 generations backK062784 Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403…Sejoy Electronics & Instruments Co., Ltd. · 2007
- 1 generation backK110776 Digital Thermometer MT SeriesSejoy Electronics & Instruments Co., Ltd. · 2011
- This deviceK153149 Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132…Sejoy Electronics & Instruments Co., Ltd. · 2016
- Descendant · cites it directly · 6 of its ownK163518 Digital ThermometerJoytech Healthcare Co., Ltd. · 2017
- Descendant · 2 generations on · 4 of its ownK183393 Digital ThermometerJoytech Healthcare Co., Ltd. · 2019
- Descendant · 3 generations on · 2 of its ownK200599 Digital ThermometerJoytech Healthcare Co., Ltd. · 2020
- Descendant · 4 generations on · 1 of its ownK223044 Digital Thermometer (Model QT001)Shen Zhen Rong Feng Technology Co., Ltd. · 2023
- Descendant · 5 generations on · 0 of its ownK240109 Medical electronic thermometer (FC01, FC02)Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K163518Digital ThermometerJoytech Healthcare Co., Ltd. · 2017 · cites it directly6descendants
- K183393Digital ThermometerJoytech Healthcare Co., Ltd. · 2019 · 2 generations on4descendants
- K200599Digital ThermometerJoytech Healthcare Co., Ltd. · 2020 · 3 generations on2descendants
- K223044Digital Thermometer (Model QT001)Shen Zhen Rong Feng Technology Co., Ltd. · 2023 · 4 generations on1descendant
- K240109Medical electronic thermometer (FC01, FC02)Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902624 | BD Flexible Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −2 | K062784 | Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403 and MT-405) | Sejoy Electronics & Instruments Co., Ltd. | 2007 | — |
| −1 | K110776 | Digital Thermometer MT Series | Sejoy Electronics & Instruments Co., Ltd. | 2011 | — |
| 0 (this device) | K153149 | Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333… | Sejoy Electronics & Instruments Co., Ltd. | 2016 | — |
| +1 | K163518 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2017 | — |
| +2 | K183393 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2019 | — |
| +3 | K200599 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2020 | — |
| +4 | K223044 | Digital Thermometer (Model QT001) | Shen Zhen Rong Feng Technology Co., Ltd. | 2023 | — |
| +5 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 26.8 · 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 |
|---|---|---|---|
| * | K110776 | Digital Thermometer MT SeriesSummary page 4…CFR 880.2910 5. Predicate Device Information: Digital Thermometers Models MT-4119 and MT-4320 manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. 510(k) number: K110776 6. Intended use / Indication for Use: The Digital Thermometers MT series are intended to measure the human body temperature in r… | 2011 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163518 | Digital Thermometer | 2017 | 6 |
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 26 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K163518 (Joytech Healthcare Co., Ltd., 2017) has gone furthest, with 6 descendants of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Digital Thermometers MT series are intended to measure the human body temperature in regular mode orally, rectally or under the arm. 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/K153149 · printed Nov 3, 2026
Cite this page
510(k) Report. “K153149: Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153149
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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