510(k) · Cleared
ClearedMicrolife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1
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 May 17, 2010 as substantially equivalent to K033820 (Microlife Intellectual Property GmbH, 2004) and 1 other predicate after a 41-day review. Its family tree reaches back 3 generations to 2000. 18 later devices descend from it.
- Decided
- May 17, 2010
- Review
- 41 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K000969 (2000). 7 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000969 Microlife Digital Infrared Ear Thermometer, Model IR1DA1Microlife Corp. · 2000
- 2 generations backK020725 Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp. · 2002
- 1 generation backK033820 Microlife Digital Infrared Forehead Thermometer, Model FR1DM1Microlife Intellectual Property GmbH · 2004
- This deviceK100953 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010
- Descendant · cites it directly · 11 of its ownK191829 Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020
- Descendant · cites it directly · 5 of its ownK150869 Checkme Pro Health MonitorViatom Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK191088 Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK211776 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B…Microlife Intellectual Property GmbH · 2022
- Descendant · 2 generations on · 1 of its ownK202420 Infrared Forehead ThermometerConmo Electronic Company Limited · 2021
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K191829Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020 · cites it directly11descendants
- K150869Checkme Pro Health MonitorViatom Technology Co., Ltd. · 2015 · cites it directly5descendants
- K191088Checkme O2 Pulse OximeterShenzhen Viatom Technology Co., Ltd. · 2019 · 2 generations on2descendants
- K211776Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)Microlife Intellectual Property GmbH · 2022 · 2 generations on1descendant
- K202420Infrared Forehead ThermometerConmo Electronic Company Limited · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000969 | Microlife Digital Infrared Ear Thermometer, Model IR1DA1 | Microlife Corp. | 2000 | — |
| −2 | K020725 | Microlife Digital Infrared Ear Thermometer, Model IR1DE1 | Microlife Corp. | 2002 | — |
| −1 | K033820 | Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 | Microlife Intellectual Property GmbH | 2004 | — |
| 0 (this device) | K100953 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1 | Microlife Intellectual Property GmbH | 2010 | — |
| +1 | K191829 | Microlife Non-Contact Infrared Forehead Thermometer | Microlife Intellectual Property GmbH | 2020 | — |
| +1 | K150869 | Checkme Pro Health Monitor | Viatom Technology Co., Ltd. | 2015 | — |
| +2 | K191088 | Checkme O2 Pulse Oximeter | Shenzhen Viatom Technology Co., Ltd. | 2019 | — |
| +2 | K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) | Microlife Intellectual Property GmbH | 2022 | — |
| +2 | K202420 | Infrared Forehead Thermometer | Conmo Electronic Company Limited | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (2)
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 |
|---|---|---|---|
| * | K033820 | Microlife Digital Infrared Forehead Thermometer, Model FR1DM1Summary page 2…olife Non-contact Infrared Forehead Thermometer, Model FRi DZ1 is substantially equivalent to Microlife Digital Infrared Forehead Thermometer, Model FRi DM1, K#033820, and Thermofocus Non-contact Infrared Forehead Thermometer, Model 01 500, K#072108, which has the same intended use and… | 2004 |
| * | K072108 | Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesSummary page 2…ivalent to Microlife Digital Infrared Forehead Thermometer, Model FRi DM1, K#033820, and Thermofocus Non-contact Infrared Forehead Thermometer, Model 01 500, K#072108, which has the same intended use and is similar in design to the predicate devices. The Microlife Non-contact Infrared… | 2007 |
What descends from it? (18)
See all 182 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 10 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K191829 (Microlife Intellectual Property GmbH, 2020) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate K033820.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Microlife Non-Contact Infrared Forehead Thermometer, Model FRi DZl 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/K100953 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100953: Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100953
Report an extraction error
Are you the manufacturer?
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