510(k) · Cleared
ClearedDuteck (Michealth)Digital Clinical Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Duteck Industrial Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Feb 4, 2014 as substantially equivalent to K992327 (Duteck Industrial Co., Ltd., 1999) after a 208-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Feb 4, 2014
- Review
- 208 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992327 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK992327 Duteck Digital Clinical ThermometerDuteck Industrial Co., Ltd. · 1999
- This deviceK132140 Duteck (Michealth)Digital Clinical ThermometerDuteck Industrial Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992327 | Duteck Digital Clinical Thermometer | Duteck Industrial Co., Ltd. | 1999 | — |
| 0 (this device) | K132140 | Duteck (Michealth)Digital Clinical Thermometer | Duteck Industrial Co., Ltd. | 2014 | — |
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 |
|---|---|---|---|
| * | K992327 | Duteck Digital Clinical ThermometerSummary page 2…Digital Clinical Duteck (micHealth) Digital Clinical OF Thermometer Thermometer, DT2306 series COMPARISON 510(K) Number K992327 New Displayed Tempeature32 0C'-42.0 0C(S9OF-109. 32.000 C-42.000 C(89.600 F-109.20 Range… | 1999 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code I'LL) is used to measure human body temperature with the following features:
The device display body temperature in digital format at LCID
The device make intended contact with patient in 2 ways
(1) Surface contact: armpit.
(2) Invasive contact: oral.
The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children.
The device is used in ENVIRONMIENT of room temperature and normal environment condition.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132140 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132140: Duteck (Michealth)Digital Clinical Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132140
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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