510(k) · Cleared
ClearedDigital Clinical Thermometer, Models ST-8A3C and ST-8A3F
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 Sep 8, 2004 as substantially equivalent to K981337 (Mesure Technology, 1998) after a 43-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Sep 8, 2004
- Review
- 43 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K981337 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK981337 Digital Clinical Thermometer, Models ST-833A & ST-834AMesure Technology · 1998
- This deviceK042013 Digital Clinical Thermometer, Models ST-8A3C and ST-8A3FMesure Technology Co., Ltd. · 2004
- 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 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −1 | K981337 | Digital Clinical Thermometer, Models ST-833A & ST-834A | Mesure Technology | 1998 | — |
| 0 (this device) | K042013 | Digital Clinical Thermometer, Models ST-8A3C and ST-8A3F | Mesure Technology Co., Ltd. | 2004 | — |
| +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 |
|---|---|---|
| 2007 | 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 26.8 · 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 |
|---|---|---|---|
| * | K981337 | Digital Clinical Thermometer, Models ST-833A & ST-834ASummary page 1…cal Thermometer, model ST-8A3C, and ST-8A3F. *Information of the 510O(k) Cleared Device (Predicate Device): Digital Clinical Thermometer, model ST-833A, and ST-834A (K981337). Device Desritin The digital clinical thermometer, models ST-8A3C, and ST-8A3F, are the electronic thermometers by using… | 1998 |
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 |
|---|---|---|---|
| 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?
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 measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal amplification, conditioning and digital LCD (display) unit. The device is reusable and intended for oral, axillary or rectal temperature measurements.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042013 · printed Nov 3, 2026
Cite this page
510(k) Report. “K042013: Digital Clinical Thermometer, Models ST-8A3C and ST-8A3F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K042013
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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