510(k) · Cleared
ClearedMicrolife Digital Infrared Forehead Thermometer, Model FR1DM1
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 Feb 23, 2004 as substantially equivalent to K020725 (Microlife Corp., 2002) after a 76-day review. Its family tree reaches back 2 generations to 2000. 23 later devices descend from it.
- Decided
- Feb 23, 2004
- Review
- 76 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000969 (2000). 3 ancestors in all. 23 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK000969 Microlife Digital Infrared Ear Thermometer, Model IR1DA1Microlife Corp. · 2000
- 1 generation backK020725 Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp. · 2002
- This deviceK033820 Microlife Digital Infrared Forehead Thermometer, Model FR1DM1Microlife Intellectual Property GmbH · 2004
- Descendant · cites it directly · 18 of its ownK100953 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010
- Descendant · 2 generations on · 11 of its ownK191829 Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020
- Descendant · 2 generations on · 5 of its ownK150869 Checkme Pro Health MonitorViatom Technology Co., Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK191088 Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK211776 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B…Microlife Intellectual Property GmbH · 2022
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K100953Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010 · cites it directly18descendants
- K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020 · 2 generations on11descendants
- K150869Checkme Pro Health MonitorViatom Technology Co., Ltd. · 2015 · 2 generations on5descendants
- K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2019 · 3 generations on2descendants
- K211776Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)Microlife Intellectual Property GmbH · 2022 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000969 | Microlife Digital Infrared Ear Thermometer, Model IR1DA1 | Microlife Corp. | 2000 | — |
| −1 | K020725 | Microlife Digital Infrared Ear Thermometer, Model IR1DE1 | Microlife Corp. | 2002 | — |
| 0 (this device) | K033820 | Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 | Microlife Intellectual Property GmbH | 2004 | — |
| +1 | K100953 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1 | Microlife Intellectual Property GmbH | 2010 | — |
| +2 | K191829 | Microlife Non-Contact Infrared Forehead Thermometer | Microlife Intellectual Property GmbH | 2020 | — |
| +2 | K150869 | Checkme Pro Health Monitor | Viatom Technology Co., Ltd. | 2015 | — |
| +3 | K191088 | Checkme O2 Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2019 | — |
| +3 | K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) | Microlife Intellectual Property GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K020725 | Microlife Digital Infrared Ear Thermometer, Model IR1DE1Summary page 1…crolife Digital Infrared Forehead Thermometer, Model FRi DM1 3. Predicate Device Information: Microlife Digital Infrared Ear Thermometer, Model IRi DEl, K#1020725 4. Device Description: The Microlife Digital Infrared Forehead Thermometer, Model FRI DM1 is an ectronic ther… | 2002 |
What descends from it? (23)
See all 233 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 4 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K100953 (Microlife Intellectual Property GmbH, 2010) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K020725.
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 Digital Infrared Forehead Thermometer, Model FRI DM1 is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033820 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033820: Microlife Digital Infrared Forehead Thermometer, Model FR1DM1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033820
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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