510(k) · Cleared
ClearedEar Thermometer, Models ST613C and ST613F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mesure Technology · FLL Continuous Measurement Thermometer
Cleared on Jul 10, 2001 after a 77-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jul 10, 2001
- Review
- 77 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK011254 Ear Thermometer, Models ST613C and ST613FMesure Technology · 2001
- Descendant · cites it directly · 1 of its ownK042627 Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65Mesure Technology Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK102935 Infrared Ear Thermometer, Models TM819, TM820, TM817, TM810A…Kingtech Enterprise, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK102934 Infrared Ear Thermometer, Model IR-04MTVega Technologies, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK080981 Ear Thermometer, Models ST66 and ST67Mesure Technology Co., Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK070578 Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and…Zen Strong Medical Technology Co., Ltd. · 2007
Most influential descendants
Showing 5 of 5 · See all- K042627Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65Mesure Technology Co., Ltd. · 2004 · cites it directly1descendant
- K102935Infrared Ear Thermometer, Models TM819, TM820, TM817, TM810A, TM810B, TM818 and TM818AKingtech Enterprise, Ltd. · 2011 · cites it directly0descendants
- K102934Infrared Ear Thermometer, Model IR-04MTVega Technologies, Inc. · 2011 · cites it directly0descendants
- K080981Ear Thermometer, Models ST66 and ST67Mesure Technology Co., Ltd. · 2008 · 2 generations on0descendants
- K070578Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared ThermometerZen Strong Medical Technology Co., Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +1 | K102935 | Infrared Ear Thermometer, Models TM819, TM820, TM817, TM810A, TM810B, TM818… | Kingtech Enterprise, Ltd. | 2011 | — |
| +1 | K102934 | Infrared Ear Thermometer, Model IR-04MT | Vega Technologies, Inc. | 2011 | — |
| +2 | K080981 | Ear Thermometer, Models ST66 and ST67 | Mesure Technology Co., Ltd. | 2008 | — |
| +1 | K070578 | Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared… | Zen Strong Medical Technology Co., Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (5)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042627 | Ear Thermometer Models ST61, ST62, ST63, ST64, and ST65 | 2004 | 1 |
| K102935 | Infrared Ear Thermometer, Models TM819, TM820, TM817, TM810A, TM810B, TM818 and TM818A | 2011 | 0 |
| K102934 | Infrared Ear Thermometer, Model IR-04MT | 2011 | 0 |
| K070578 | Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared Thermometer | 2007 | 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?
- Of its descendants, K042627 (Mesure Technology Co., Ltd., 2004) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K011254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011254: Ear Thermometer, Models ST613C and ST613F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011254
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026