510(k) · Cleared
ClearedDigital Clinical Thermometer, Models ST-833A & ST-834A
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 Sep 30, 1998 after a 170-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Sep 30, 1998
- Review
- 170 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK981337 Digital Clinical Thermometer, Models ST-833A & ST-834AMesure Technology · 1998
- Descendant · cites it directly · 1 of its ownK042013 Digital Clinical Thermometer, Models ST-8A3C and ST-8A3FMesure Technology Co., Ltd. · 2004
- Descendant · cites it directly · 0 of its ownK112703 Shaker Digital ThermometerMeasure Technology Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK070578 Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and…Zen Strong Medical Technology Co., Ltd. · 2007
Most influential descendants
Showing 3 of 3 · See all- K042013Digital Clinical Thermometer, Models ST-8A3C and ST-8A3FMesure Technology Co., Ltd. · 2004 · cites it directly1descendant
- K112703Shaker Digital ThermometerMeasure Technology Co., Ltd. · 2011 · cites it directly0descendants
- K070578Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared ThermometerZen Strong Medical Technology Co., Ltd. · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981337 | Digital Clinical Thermometer, Models ST-833A & ST-834A | Mesure Technology | 1998 | — |
| +1 | K042013 | Digital Clinical Thermometer, Models ST-8A3C and ST-8A3F | Mesure Technology Co., Ltd. | 2004 | — |
| +1 | K112703 | Shaker Digital Thermometer | Measure Technology Co., Ltd. | 2011 | — |
| +2 | 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 |
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
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, K042013 (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 | — |
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 read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981337: Digital Clinical Thermometer, Models ST-833A & ST-834A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981337
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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