510(k) · Cleared
ClearedMicrolife Digital Infrared Ear Thermometer, Model IR1DE1-1
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 Jan 15, 2004 as substantially equivalent to K020725 (Microlife Corp., 2002) after a 17-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.
- Decided
- Jan 15, 2004
- Review
- 17 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. 6 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 deviceK034023 Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1Microlife Intellectual Property GmbH · 2004
- Descendant · cites it directly · 2 of its ownK091040 Microlife Digital Infrared Ear Thermometer, Model Iridvi-1Microlife Intellectual Property GmbH · 2009
- Descendant · cites it directly · 1 of its ownK170219 Microlife Digital Infrared Ear ThermometerMicrolife Intellectual Property GmbH · 2017
- Descendant · 2 generations on · 1 of its ownK113141 Microlife Dual Mode Thermometer,Model IFR1MJ1Microlife Intellectual Property GmbH · 2012
- Descendant · 2 generations on · 0 of its ownK182401 B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff…Amzetta Technologies Private Limited · 2019
- Descendant · 3 generations on · 0 of its ownK163256 Dual Mode Infrared ThermometerIntelliworks, LLC · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K091040Microlife Digital Infrared Ear Thermometer, Model Iridvi-1Microlife Intellectual Property GmbH · 2009 · cites it directly2descendants
- K170219Microlife Digital Infrared Ear ThermometerMicrolife Intellectual Property GmbH · 2017 · cites it directly1descendant
- K113141Microlife Dual Mode Thermometer,Model IFR1MJ1Microlife Intellectual Property GmbH · 2012 · 2 generations on1descendant
- K182401B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared…Amzetta Technologies Private Limited · 2019 · 2 generations on0descendants
- K163256Dual Mode Infrared ThermometerIntelliworks, LLC · 2017 · 3 generations on0descendants
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) | K034023 | Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1 | Microlife Intellectual Property GmbH | 2004 | — |
| +1 | K091040 | Microlife Digital Infrared Ear Thermometer, Model Iridvi-1 | Microlife Intellectual Property GmbH | 2009 | — |
| +1 | K170219 | Microlife Digital Infrared Ear Thermometer | Microlife Intellectual Property GmbH | 2017 | — |
| +2 | K113141 | Microlife Dual Mode Thermometer,Model IFR1MJ1 | Microlife Intellectual Property GmbH | 2012 | — |
| +2 | K182401 | B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T… | Amzetta Technologies Private Limited | 2019 | — |
| +3 | K163256 | Dual Mode Infrared Thermometer | Intelliworks, LLC | 2017 | — |
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 |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 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…Ear Thermometer, Model IR1DEl-1 3. Information for the 510(k) Cleared Device (Predicate Device): Microlife Digital Infrared Ear Thermometer, Model IR1 DE1, K#020725 4. Device Description: The Microlife Digital Infrared Ear Thermometer, Model IR1 DE1-1 is an electronic thermome… | 2002 |
What descends from it? (6)
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 4 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K091040 (Microlife Intellectual Property GmbH, 2009) has gone furthest, with 2 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 device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K034023 · printed Nov 5, 2026
Cite this page
510(k) Report. “K034023: Microlife Digital Infrared Ear Thermometer, Model IR1DE1-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K034023
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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