510(k) · Cleared

Cleared

Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F

K023956510(k) TraditionalCleared Jun 17, 2004568-day reviewClass II21 CFR 880.2910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mesure Technology Co., Ltd. · FLL Continuous Measurement Thermometer

Cleared on Jun 17, 2004 as substantially equivalent to K003326 (Funai Radio & Communications Corp., 2001) after a 568-day review. Its family tree reaches back 1 generation to 2001. 34 later devices descend from it.

Decided: Jun 17, 2004
Review: 568 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K003326 (2001). 34 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK003326 Funet Amy Mama Body ThermometerFunai Radio & Communications Corp. · 2001
This deviceK023956 Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F…Mesure Technology Co., Ltd. · 2004
Descendant · cites it directly · 33 of its ownK063542 Wireless Temperature Monitor / Models ST323C and ST323F.Mesure Technology Co., Ltd. · 2007
Descendant · 2 generations on · 32 of its ownK143267 TempTraq TT-100Blue Spark Technologies, Inc. · 2015
Descendant · 3 generations on · 29 of its ownK162137 Fever Scout™ Continuous Monitoring thermometerVivaLNK, Inc. · 2017
Descendant · 4 generations on · 26 of its ownK181013 Fever ScoutVivaLNK, Inc. · 2018
Descendant · 5 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2007high 7 (2024) · low 0 (2008)2026

Most influential descendants

Showing 5 of 34 · See all

K063542Wireless Temperature Monitor / Models ST323C and ST323F.Mesure Technology Co., Ltd. · 2007 · cites it directly33descendants
K143267TempTraq TT-100Blue Spark Technologies, Inc. · 2015 · 2 generations on32descendants
K162137Fever Scout™ Continuous Monitoring thermometerVivaLNK, Inc. · 2017 · 3 generations on29descendants
K181013Fever ScoutVivaLNK, Inc. · 2018 · 4 generations on26descendants
K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 5 generations on16descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K003326	Funet Amy Mama Body Thermometer	Funai Radio & Communications Corp.	2001	—
0 (this device)	K023956	Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F	Mesure Technology Co., Ltd.	2004	—
+1	K063542	Wireless Temperature Monitor / Models ST323C and ST323F.	Mesure Technology Co., Ltd.	2007	—
+2	K143267	TempTraq TT-100	Blue Spark Technologies, Inc.	2015	—
+3	K162137	Fever Scout™ Continuous Monitoring thermometer	VivaLNK, Inc.	2017	—
+4	K181013	Fever Scout	VivaLNK, Inc.	2018	—
+5	K191272	Wearable Device, Wearable Package	Current Health, Ltd.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
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

FIG. 1 — Lineage of K023956, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K003326	Funet Amy Mama Body Thermometer Summary page 1 …ireless temperature monitor, model ST-314C/F, ST313C/F. 2. Information of the 510(k) Cleared Device (Predicate Device): Wireless thermometer monitor; model RT-9101 (K003326). 3. Device Description: The Wireless temperature monitor, model ST-314C/F, ST313C/F, are the electronic thermometers by…	Funai Radio & Communications Corp.	2001	—

Also cleared against K003326: 4 other devices →

What descends from it? (34)

See all 34

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063542	Wireless Temperature Monitor / Models ST323C and ST323F.	Mesure Technology Co., Ltd.	2007	33

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?

Its one ancestor has no recall.
Of its descendants, K063542 (Mesure Technology Co., Ltd., 2007) has gone furthest, with 33 descendants of its own.
4 other devices also cite its predicate K003326.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLL

6in 2025

2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007high 295 (2023) · low 59 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FLL

1in 2025

2007high 5 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FLL

73in 2025

2007high 142 (2022) · low 4 (2007)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 ST313C/F, ST314C/F are the battery-operated electronic devices with intended use of measuring human body temperature precisely. This device is reusable and intended for wrist and abdomen temperature measurement of the baby less than eight years old, and the baby of eight years old.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023956 · printed Nov 4, 2026

Cite this page

510(k) Report. “K023956: Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023956

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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