510(k) · Cleared
ClearedSejoy, Model MT-403
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 Feb 6, 2006 after a 227-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Feb 6, 2006
- Review
- 227 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK051699 Sejoy, Model MT-403Sejoy Electronics & Instruments Co., Ltd. · 2006
- 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K051699 | Sejoy, Model MT-403 | Sejoy Electronics & Instruments Co., Ltd. | 2006 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110776 | Digital Thermometer MT Series | 2011 | 8 |
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?
- 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.
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 device model MT-101 is intended to measure the human body temperature in regular mode orally, rectally or under the arm(axillary). The device is reusable for clinical or home use on people of all ages.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051699: Sejoy, Model MT-403.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051699
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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