510(k) · Cleared
ClearedEar Thermometer, Models ST66 and ST67
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mesure Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on May 2, 2008 as substantially equivalent to K042627 (Mesure Technology Co., Ltd., 2004) after a 25-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- May 2, 2008
- Review
- 25 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011254 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK011254 Ear Thermometer, Models ST613C and ST613FMesure Technology · 2001
- 1 generation backK042627 Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65Mesure Technology Co., Ltd. · 2004
- This deviceK080981 Ear Thermometer, Models ST66 and ST67Mesure Technology Co., Ltd. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011254 | Ear Thermometer, Models ST613C and ST613F | Mesure Technology | 2001 | — |
| −1 | K042627 | Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65 | Mesure Technology Co., Ltd. | 2004 | — |
| 0 (this device) | K080981 | Ear Thermometer, Models ST66 and ST67 | Mesure Technology Co., Ltd. | 2008 | — |
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 26.8 · 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 |
|---|---|---|---|
| * | K042627 | Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65 Our reading of the summary gave K040627, FDA’s number for Depuy Asr Modular Acetabular Cup System (DePuy Orthopaedics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ear Thermometer Model ST64 & ST65”. | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 measures the body temperature from the auditory canal of of a patient by means of an infrared sensor coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for home use on people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080981 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080981: Ear Thermometer, Models ST66 and ST67.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080981
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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