510(k) · Cleared
ClearedBelter Infra-Red Ear Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Belter Health Measurement and Analysis TE · FLL Continuous Measurement Thermometer
Cleared on Aug 21, 2014 as substantially equivalent to K111637 (Radiant Innovation, Inc., 2011) after a 156-day review. Its family tree reaches back 1 generation to 2011. 1 later device descends from it.
- Decided
- Aug 21, 2014
- Review
- 156 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K111637 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK111637 Infrared Ear ThermometerRadiant Innovation, Inc. · 2011
- This deviceK140681 Belter Infra-Red Ear ThermometerShenzhen Belter Health Measurement and Analysis TE · 2014
- Descendant · cites it directly · 0 of its ownK180314 Infrared ThermometerXuzhou Yongkang Electronic Science Technology Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180314Infrared ThermometerXuzhou Yongkang Electronic Science Technology Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K111637 | Infrared Ear Thermometer | Radiant Innovation, Inc. | 2011 | — |
| 0 (this device) | K140681 | Belter Infra-Red Ear Thermometer | Shenzhen Belter Health Measurement and Analysis TE | 2014 | — |
| +1 | K180314 | Infrared Thermometer | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K111637 | Infrared Ear ThermometerSummary page 4…mometer, Electronic, Clinical Production regulation: 21 CFR 880.2910 Product code: FLL Predicate Device Infrared Ear Thermometer THP Series (Radiant Innovation Inc,FLL,K111637) Description The Belter Infra-red Ear Thermometer is characterized by measuring human body temperature from the ear canal. It u… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180314 | Infrared Thermometer | 2018 | 0 |
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?
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Belter Infra-red Ear thermometer is an electronic thermometer using an infrared
sensor to detect human body temperature from the ear canal on people of all ages for
home and professional use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140681: Belter Infra-Red 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/K140681
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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