510(k) · Cleared
ClearedSejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403 and MT-405)
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 4, 2007 as substantially equivalent to K945427 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1995) and 2 other predicates after a 228-day review. Its family tree reaches back 1 generation to 1990. 11 later devices descend from it.
- Decided
- May 4, 2007
- Review
- 228 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K902624 (1990). 3 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK902624 BD Flexible Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- This deviceK062784 Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403…Sejoy Electronics & Instruments Co., Ltd. · 2007
- Descendant · cites it directly · 8 of its ownK110776 Digital Thermometer MT SeriesSejoy Electronics & Instruments Co., Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK153149 Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132…Sejoy Electronics & Instruments Co., Ltd. · 2016
- Descendant · 3 generations on · 6 of its ownK163518 Digital ThermometerJoytech Healthcare Co., Ltd. · 2017
- Descendant · 4 generations on · 4 of its ownK183393 Digital ThermometerJoytech Healthcare Co., Ltd. · 2019
- Descendant · 5 generations on · 2 of its ownK200599 Digital ThermometerJoytech Healthcare Co., Ltd. · 2020
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K110776Digital Thermometer MT SeriesSejoy Electronics & Instruments Co., Ltd. · 2011 · cites it directly8descendants
- K153149Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326…Sejoy Electronics & Instruments Co., Ltd. · 2016 · 2 generations on7descendants
- K163518Digital ThermometerJoytech Healthcare Co., Ltd. · 2017 · 3 generations on6descendants
- K183393Digital ThermometerJoytech Healthcare Co., Ltd. · 2019 · 4 generations on4descendants
- K200599Digital ThermometerJoytech Healthcare Co., Ltd. · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902624 | BD Flexible Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| 0 (this device) | 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 | — |
| +2 | K153149 | Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333… | Sejoy Electronics & Instruments Co., Ltd. | 2016 | — |
| +3 | K163518 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2017 | — |
| +4 | K183393 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2019 | — |
| +5 | K200599 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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 26.7 · 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? (3)
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 |
|---|---|---|---|
| * | K945427 | B-D Digital ThermometerSummary page 1…MT-405 3. Predicate Device Information: For submitted devices MT-201 and MT-301: 0 * BD DIGITAL THERMOMETER 510(k) number: K945427 c Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALY… | 1995 |
| * | K902624 | BD Flexible Digital ThermometerSummary page 1…INER SYSTEMS PREANALYIC Owner: BECTON, DICKINSON & CO. For submitted devices MT-402 and MT-403: *BD FLEXIBLE DIGITAL THERMOMETER 510(k) number: K902624 Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYIC Owner: BECTON, DICKINSON & CO. For submitted… | 1990 |
| * | K041694 | Digital Flexible Thermometer, Basic Digital Thermometer, Ditital Pacifier ThermometerSummary page 1…UTAINER SYSTEMS PREANALYIC Owner: BECTON, DICKINSON & CO. For submitted device MT-405: *Digital Pacifier Thermometer Model NT-01 5 10(k) number: K041694 Applicant: Hangzhou Hua'an Medical & Health Instrument Company Limited Owner: Hangzhou Hua'an Medical & Health Instrument… | 2004 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K110776 (Sejoy Electronics & Instruments Co., Ltd., 2011) has gone furthest, with 8 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. 2007, 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 model MT series digital thermometers (MT-201, 301, 402 and 403) 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.
The device model MT-405 is intended to measure oral temperature only. It is reusable for clinical or home use for children under the age of four.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062784: Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403 and MT-405).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062784
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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