510(k) · Cleared
ClearedMicrolife Instant Digital Electronic Thermometer, Model MT18L1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microlife Intellectual Property GmbH · FLL Continuous Measurement Thermometer
Cleared on Dec 9, 2004 as substantially equivalent to K031958 (Microlife Intellectual Property GmbH, 2003) after a 29-day review. Its family tree reaches back 4 generations to 1995. 5 later devices descend from it.
- Decided
- Dec 9, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943695 (1995). 5 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK943695 SuretempAdvanced Bioresearch Assoc. · 1995
- 3 generations backK990168 Microlife IT2CA1Microlife Systems AG · 1999
- 2 generations backK012136 Avita Agil IT 101 Instant Digital ThermometerAvita Corporation · 2001
- 1 generation backK031958 Microlife Instant Digital Electronic Thermometer, Model QT1JA1Microlife Intellectual Property GmbH · 2003
- This deviceK043110 Microlife Instant Digital Electronic Thermometer, Model MT18L1Microlife Intellectual Property GmbH · 2004
- Descendant · cites it directly · 3 of its ownK152975 VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016
- Descendant · cites it directly · 2 of its ownK180131 Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
- Descendant · 2 generations on · 1 of its ownK202791 iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK211352 Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK070590 Microlife Instant Digital Electronic Thermometer, Model MT19S1RMicrolife Intellectual Property GmbH · 2007
Most influential descendants
Showing 5 of 5 · See all- K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016 · cites it directly3descendants
- K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018 · cites it directly2descendants
- K202791iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021 · 2 generations on1descendant
- K211352Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. · 2021 · 3 generations on0descendants
- K070590Microlife Instant Digital Electronic Thermometer, Model MT19S1RMicrolife Intellectual Property GmbH · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943695 | Suretemp | Advanced Bioresearch Assoc. | 1995 | — |
| −3 | K990168 | Microlife IT2CA1 | Microlife Systems AG | 1999 | — |
| −2 | K012136 | Avita Agil IT 101 Instant Digital Thermometer | Avita Corporation | 2001 | — |
| −1 | K031958 | Microlife Instant Digital Electronic Thermometer, Model QT1JA1 | Microlife Intellectual Property GmbH | 2003 | — |
| 0 (this device) | K043110 | Microlife Instant Digital Electronic Thermometer, Model MT18L1 | Microlife Intellectual Property GmbH | 2004 | — |
| +1 | K152975 | VDT985US Vicks SmartTemp Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2016 | — |
| +1 | K180131 | Vicks RapidRead Digital Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2018 | — |
| +2 | K202791 | iHealth Clinical Digital Thermometer | Andon Health Co, Ltd. | 2021 | — |
| +3 | K211352 | Electronic Thermometer (XHF2001, XHF2002) | Putian Hanjiang Huafeng Plastic Co., Ltd. | 2021 | — |
| +1 | K070590 | Microlife Instant Digital Electronic Thermometer, Model MT19S1R | Microlife Intellectual Property GmbH | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K031958 | Microlife Instant Digital Electronic Thermometer, Model QT1JA1Summary page 1…rolife Instant Digital Electronic Thermometer, Model MT1 811 3. Predicate Device Information: Microlife Instant Digital Electronic Thermometer, Model QT1JA1, K#031958, 4. Device Description: This predictive (instant) digital electronic thermometer enables very fast and reliable m… | 2003 |
What descends from it? (5)
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?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K152975 (Kaz USA, Inc., A Helen of Troy Company, 2016) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K031958.
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 Microlife MT 1811 Instant Digital Thermometer is used for the
intermittent measurement and monitoring of human body temperature,
orally, rectally and under the arm. The device is for the adult and pediatric
population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043110: Microlife Instant Digital Electronic Thermometer, Model MT18L1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043110
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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