510(k) · Cleared
ClearedInfrared Ear Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiant Innovation, Inc. · FLL Continuous Measurement Thermometer
Cleared on Dec 6, 2011 after a 176-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 later devices descend from it.
- Decided
- Dec 6, 2011
- Review
- 176 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
5 later devices descend from it, 2 citing it directly.
- This deviceK111637 Infrared Ear ThermometerRadiant Innovation, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK120144 Vital Signs MonitorEdan Instruments, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK140681 Belter Infra-Red Ear ThermometerShenzhen Belter Health Measurement and Analysis TE · 2014
- Descendant · 2 generations on · 1 of its ownK131818 Vital Signs MonitorEdan Instruments, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 0 of its ownK180380 vital signs monitorEdan Instruments, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK180314 Infrared ThermometerXuzhou Yongkang Electronic Science Technology Co., Ltd. · 2018
Most influential descendants
Showing 5 of 5 · See all- K120144Vital Signs MonitorEdan Instruments, Inc. · 2012 · cites it directly2descendants
- K140681Belter Infra-Red Ear ThermometerShenzhen Belter Health Measurement and Analysis TE · 2014 · cites it directly1descendant
- K131818Vital Signs MonitorEdan Instruments, Inc. · 2013 · 2 generations on1descendant
- K180380vital signs monitorEdan Instruments, Inc. · 2018 · 3 generations on0descendants
- K180314Infrared ThermometerXuzhou Yongkang Electronic Science Technology Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111637 | Infrared Ear Thermometer | Radiant Innovation, Inc. | 2011 | — |
| +1 | K120144 | Vital Signs Monitor | Edan Instruments, Inc. | 2012 | — |
| +1 | K140681 | Belter Infra-Red Ear Thermometer | Shenzhen Belter Health Measurement and Analysis TE | 2014 | — |
| +2 | K131818 | Vital Signs Monitor | Edan Instruments, Inc. | 2013 | 2 |
| +3 | K180380 | vital signs monitor | Edan Instruments, Inc. | 2018 | 1 |
| +2 | K180314 | Infrared Thermometer | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K0011059 | Radiant Innovation Infrared Ear Thermometer, Models TH8 series Number could not be read |
What descends from it? (5)
2 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?
- Of its descendants, K120144 (Edan Instruments, Inc., 2012) has gone furthest, with 2 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. 2011, 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 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/K111637 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111637: Infrared Ear Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111637
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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