510(k) · Cleared
ClearedWireless Temperature Monitor / Models ST323C and ST323F.
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 Apr 10, 2007 as substantially equivalent to K023956 (Mesure Technology Co., Ltd., 2004) after a 137-day review. Its family tree reaches back 2 generations to 2001. 33 later devices descend from it.
- Decided
- Apr 10, 2007
- Review
- 137 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003326 (2001). 33 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK003326 Funet Amy Mama Body ThermometerFunai Radio & Communications Corp. · 2001
- 1 generation backK023956 Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F…Mesure Technology Co., Ltd. · 2004
- This deviceK063542 Wireless Temperature Monitor / Models ST323C and ST323F.Mesure Technology Co., Ltd. · 2007
- Descendant · cites it directly · 32 of its ownK143267 TempTraq TT-100Blue Spark Technologies, Inc. · 2015
- Descendant · 2 generations on · 29 of its ownK162137 Fever Scout™ Continuous Monitoring thermometerVivaLNK, Inc. · 2017
- Descendant · 3 generations on · 26 of its ownK181013 Fever ScoutVivaLNK, Inc. · 2018
- Descendant · 4 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- Descendant · 5 generations on · 8 of its ownK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K143267TempTraq TT-100Blue Spark Technologies, Inc. · 2015 · cites it directly32descendants
- K162137Fever Scout™ Continuous Monitoring thermometerVivaLNK, Inc. · 2017 · 2 generations on29descendants
- K181013Fever ScoutVivaLNK, Inc. · 2018 · 3 generations on26descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 4 generations on16descendants
- K210133Current Health Monitoring System Gen 2 (G2)Current Health · 2021 · 5 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003326 | Funet Amy Mama Body Thermometer | Funai Radio & Communications Corp. | 2001 | — |
| −1 | K023956 | Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F | Mesure Technology Co., Ltd. | 2004 | — |
| 0 (this device) | K063542 | Wireless Temperature Monitor / Models ST323C and ST323F. | Mesure Technology Co., Ltd. | 2007 | — |
| +1 | K143267 | TempTraq TT-100 | Blue Spark Technologies, Inc. | 2015 | — |
| +2 | K162137 | Fever Scout™ Continuous Monitoring thermometer | VivaLNK, Inc. | 2017 | — |
| +3 | K181013 | Fever Scout | VivaLNK, Inc. | 2018 | — |
| +4 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
| +5 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K023956 | Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/FSummary page 1…temperature monitor, model ST323C and ST323F. 2. Information of the 510(k) Cleared Device (Predicate Device): Wireless thermometer monitor; model ST313C and ST313F (K023956). 3. Device Description: The ST323C and ST323F are the wireless temperature monitor intended to be worn at left arm to mon… | 2004 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143267 | TempTraq TT-100 | 2015 | 32 |
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 6 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143267 (Blue Spark Technologies, Inc., 2015) has gone furthest, with 32 descendants 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. 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 wireless temperature monitor, model ST323C, ST323F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for armpit temperature measurement of the person of all age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063542 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063542: Wireless Temperature Monitor / Models ST323C and ST323F..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063542
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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