510(k) · Cleared
ClearedMicrolife Instant Digital Electronic Thermometer, Model QT1JA1
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 Aug 15, 2003 as substantially equivalent to K012136 (Avita Corporation, 2001) after a 51-day review. Its family tree reaches back 3 generations to 1995. 8 later devices descend from it.
- Decided
- Aug 15, 2003
- Review
- 51 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K943695 (1995). 8 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK943695 SuretempAdvanced Bioresearch Assoc. · 1995
- 2 generations backK990168 Microlife IT2CA1Microlife Systems AG · 1999
- 1 generation backK012136 Avita Agil IT 101 Instant Digital ThermometerAvita Corporation · 2001
- This deviceK031958 Microlife Instant Digital Electronic Thermometer, Model QT1JA1Microlife Intellectual Property GmbH · 2003
- Descendant · cites it directly · 5 of its ownK043110 Microlife Instant Digital Electronic Thermometer, Model MT18L1Microlife Intellectual Property GmbH · 2004
- Descendant · 2 generations on · 3 of its ownK152975 VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016
- Descendant · 2 generations on · 2 of its ownK180131 Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
- Descendant · 3 generations on · 1 of its ownK202791 iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021
- Descendant · 4 generations on · 0 of its ownK211352 Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K043110Microlife Instant Digital Electronic Thermometer, Model MT18L1Microlife Intellectual Property GmbH · 2004 · cites it directly5descendants
- K152975VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016 · 2 generations on3descendants
- K180131Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018 · 2 generations on2descendants
- K202791iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021 · 3 generations on1descendant
- K211352Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943695 | Suretemp | Advanced Bioresearch Assoc. | 1995 | — |
| −2 | K990168 | Microlife IT2CA1 | Microlife Systems AG | 1999 | — |
| −1 | K012136 | Avita Agil IT 101 Instant Digital Thermometer | Avita Corporation | 2001 | — |
| 0 (this device) | K031958 | Microlife Instant Digital Electronic Thermometer, Model QT1JA1 | Microlife Intellectual Property GmbH | 2003 | — |
| +1 | K043110 | Microlife Instant Digital Electronic Thermometer, Model MT18L1 | Microlife Intellectual Property GmbH | 2004 | — |
| +2 | K152975 | VDT985US Vicks SmartTemp Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2016 | — |
| +2 | K180131 | Vicks RapidRead Digital Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2018 | — |
| +3 | K202791 | iHealth Clinical Digital Thermometer | Andon Health Co, Ltd. | 2021 | — |
| +4 | K211352 | Electronic Thermometer (XHF2001, XHF2002) | Putian Hanjiang Huafeng Plastic Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K012136 | Avita Agil IT 101 Instant Digital ThermometerSummary page 1…the Device: Microlife Instant Digital Electronic Thermometer, Model QTI JAI 3. Predicate Device Information: AVITA Instant Thermometer, Model IT101, K#012136, AVITA International Corporation 4. Device Description: This predictive (instant) digital electronic thermometer… | 2001 |
What descends from it? (8)
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 8 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K043110 (Microlife Intellectual Property GmbH, 2004) has gone furthest, with 5 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 Microlife Instant Digital Thermometer, Model, QT1JA1 is used for the intermittent measurement and monitoring of human body temperature, orally, rectally and under the arm.
The Microlife Instant Digital Thermometer, Model, QT1JA1 is a hand-held, non-sterile, reusable clinical thermometer intended for the determination of human temperature in either predictive (Instant) mode (5- seconds orally, 7- seconds rectally and under the arm-predictive temperature), or standard mode (actual determination of temperature).
The device is for the adult and pediatric population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031958: Microlife Instant Digital Electronic Thermometer, Model QT1JA1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031958
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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