510(k) · Cleared
ClearedClinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zen Strong Medical Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jul 11, 2007 as substantially equivalent to K042013 (Mesure Technology Co., Ltd., 2004) and 1 other predicate after a 132-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Jul 11, 2007
- Review
- 132 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K981337 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK981337 Digital Clinical Thermometer, Models ST-833A & ST-834AMesure Technology · 1998
- 1 generation backK042013 Digital Clinical Thermometer, Models ST-8A3C and ST-8A3FMesure Technology Co., Ltd. · 2004
- This deviceK070578 Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and…Zen Strong Medical Technology Co., Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K070578 | Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared… | Zen Strong Medical Technology Co., Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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? (2)
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 |
|---|---|---|---|
| * | K042013 | Digital Clinical Thermometer, Models ST-8A3C and ST-8A3FSummary page 2…ison to the 510(k) Cleared Device (Predicate Device): - The digital thermometer model ZSDT-XXX is to be compared to the Mesure digital thermometer, model ST8A3C (K042013). - The infrared thermometer model ZSET-XXX is to be compared to the Mesure ear thermometer, model ST613C (K011254). 6.… | 2004 |
| * | K011254 | Ear Thermometer, Models ST613C and ST613FSummary page 2…Mesure digital thermometer, model ST8A3C (K042013). - The infrared thermometer model ZSET-XXX is to be compared to the Mesure ear thermometer, model ST613C (K011254). 6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows: Compliance to applic… | 2001 |
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 9 years and passes through 3 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 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. 2007, 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 clinical thermometer / model ZSDT-XXX digital thermometer measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal processor and digital LCD (display) unit. The device is reusable and intended for oral, rectal, or armpit temperature measurement for home use on people at all ages. The clinical thermometer / model ZSET-XXX infrared thermometer are the battery-operated electronic devices with…
Read the full statement (113 words)
The clinical thermometer / model ZSDT-XXX digital thermometer measures the body temperature of a patient by means of a sensor (transducer) coupled with an electronic signal processor and digital LCD (display) unit. The device is reusable and intended for oral, rectal, or armpit temperature measurement for home use on people at all ages.
The clinical thermometer / model ZSET-XXX infrared thermometer are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD (display) unit. The device is a reusable and intended for home use, on people at all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070578 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070578: Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070578
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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