510(k) · Cleared
ClearedDigital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joytech Healthcare Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Nov 18, 2019 as substantially equivalent to K163518 (Joytech Healthcare Co., Ltd., 2017) after a 346-day review. Its family tree reaches back 5 generations to 1990. 4 later devices descend from it.
- Decided
- Nov 18, 2019
- Review
- 346 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K902624 (1990). 8 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK902624 BD Flexible Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 4 generations backK062784 Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403…Sejoy Electronics & Instruments Co., Ltd. · 2007
- 3 generations backK110776 Digital Thermometer MT SeriesSejoy Electronics & Instruments Co., Ltd. · 2011
- 2 generations backK153149 Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132…Sejoy Electronics & Instruments Co., Ltd. · 2016
- 1 generation backK163518 Digital ThermometerJoytech Healthcare Co., Ltd. · 2017
- This deviceK183393 Digital ThermometerJoytech Healthcare Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK200599 Digital ThermometerJoytech Healthcare Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK223044 Digital Thermometer (Model QT001)Shen Zhen Rong Feng Technology Co., Ltd. · 2023
- Descendant · 3 generations on · 0 of its ownK240109 Medical electronic thermometer (FC01, FC02)Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK213485 Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and…Shenzhen AOJ Medical Technology Co., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K200599Digital ThermometerJoytech Healthcare Co., Ltd. · 2020 · cites it directly2descendants
- K223044Digital Thermometer (Model QT001)Shen Zhen Rong Feng Technology Co., Ltd. · 2023 · 2 generations on1descendant
- K240109Medical electronic thermometer (FC01, FC02)Zhuzhou Goldenhot Medical Technology Co., Ltd. · 2024 · 3 generations on0descendants
- K213485Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25EShenzhen AOJ Medical Technology Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K902624 | BD Flexible Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −4 | K062784 | Sejoy Digital Thermometer, MT Series (MT-201, MT-301, MT-402, MT-403 and MT-405) | Sejoy Electronics & Instruments Co., Ltd. | 2007 | — |
| −3 | 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 | — |
| −1 | K163518 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2017 | — |
| 0 (this device) | K183393 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2019 | — |
| +1 | K200599 | Digital Thermometer | Joytech Healthcare Co., Ltd. | 2020 | — |
| +2 | K223044 | Digital Thermometer (Model QT001) | Shen Zhen Rong Feng Technology Co., Ltd. | 2023 | — |
| +3 | K240109 | Medical electronic thermometer (FC01, FC02) | Zhuzhou Goldenhot Medical Technology Co., Ltd. | 2024 | — |
| +1 | K213485 | Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E | Shenzhen AOJ Medical Technology Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K163518 | Digital ThermometerSummary page 5…Information: The Digital Thermometers are substantially equivalent to the following devices: Digital Thermometers, Models: DMT series； FDA 510(k)number: K163518； Manufactured by JOYTECH HEALTHCARE CO., LTD. 6. Intended use / Indication for Use: The Digital Thermometers DM… | 2017 |
What descends from it? (4)
2 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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K200599 (Joytech Healthcare Co., Ltd., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K163518.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. And the devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183393 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183393: Digital Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183393
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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