510(k) · Cleared
ClearedDigital Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Idea Instrument Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on May 23, 1985 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 23, 1985
- Review
- 63 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK851146 Digital ThermometerMicro Idea Instrument Co., Ltd. · 1985
- Descendant · cites it directly · 1 of its ownK032364 Microlife Digital Underarm Electronic Thermometer, Model MT 18E1…Microlife Intellectual Property GmbH · 2003
- Descendant · 2 generations on · 0 of its ownK103680 Microlife Digital Underarm ThermometerMicrolife Intellectual Property GmbH · 2011
- Descendant · cites it directly · 0 of its ownK091589 Microlife Digital Electronic Thermometer, Model MT16K1Microlife Intellectual Property GmbH · 2009
- Descendant · cites it directly · 0 of its ownK032658 Microlife Model MT18E1-1 (V932-1) Digital Underarm Electronic…Microlife Intellectual Property GmbH · 2003
Most influential descendants
Showing 4 of 4 · See all- K032364Microlife Digital Underarm Electronic Thermometer, Model MT 18E1 (V932)Microlife Intellectual Property GmbH · 2003 · cites it directly1descendant
- K103680Microlife Digital Underarm ThermometerMicrolife Intellectual Property GmbH · 2011 · 2 generations on0descendants
- K091589Microlife Digital Electronic Thermometer, Model MT16K1Microlife Intellectual Property GmbH · 2009 · cites it directly0descendants
- K032658Microlife Model MT18E1-1 (V932-1) Digital Underarm Electronic ThermometerMicrolife Intellectual Property GmbH · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K851146 | Digital Thermometer | Micro Idea Instrument Co., Ltd. | 1985 | — |
| +1 | K032364 | Microlife Digital Underarm Electronic Thermometer, Model MT 18E1 (V932) | Microlife Intellectual Property GmbH | 2003 | — |
| +2 | K103680 | Microlife Digital Underarm Thermometer | Microlife Intellectual Property GmbH | 2011 | — |
| +1 | K091589 | Microlife Digital Electronic Thermometer, Model MT16K1 | Microlife Intellectual Property GmbH | 2009 | — |
| +1 | K032658 | Microlife Model MT18E1-1 (V932-1) Digital Underarm Electronic Thermometer | Microlife Intellectual Property GmbH | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
3 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?
- Of its descendants, K032364 (Microlife Intellectual Property GmbH, 2003) has gone furthest, with 1 descendant 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 | — |
https://510kreport.com/device/K851146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K851146: Digital Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K851146
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026