510(k) · Cleared

Cleared

Fever Scout™ Continuous Monitoring thermometer

K162137510(k) TraditionalCleared Jan 19, 2017171-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

VivaLNK, Inc. · FLL Continuous Measurement Thermometer

Cleared on Jan 19, 2017 as substantially equivalent to K143267 (Blue Spark Technologies, Inc., 2015) after a 171-day review. Its family tree reaches back 4 generations to 2001. 29 later devices descend from it.

Decided: Jan 19, 2017
Review: 171 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K003326 (2001). 29 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 4 generations backK003326 Funet Amy Mama Body ThermometerFunai Radio & Communications Corp. · 2001
3 generations backK023956 Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F…Mesure Technology Co., Ltd. · 2004
2 generations backK063542 Wireless Temperature Monitor / Models ST323C and ST323F.Mesure Technology Co., Ltd. · 2007
1 generation backK143267 TempTraq TT-100Blue Spark Technologies, Inc. · 2015
This deviceK162137 Fever Scout™ Continuous Monitoring thermometerVivaLNK, Inc. · 2017
Descendant · cites it directly · 26 of its ownK181013 Fever ScoutVivaLNK, Inc. · 2018
Descendant · 2 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
Descendant · 3 generations on · 8 of its ownK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
Descendant · 3 generations on · 7 of its ownK221282 Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
Descendant · 4 generations on · 4 of its ownK230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care…Empatica S.r.l. · 2023

Showing 5 of 29 descendants. See all descendants

Descendants cleared per year

2018high 6 (2024) · low 1 (2018)2026

Most influential descendants

Showing 5 of 29 · See all

K181013Fever ScoutVivaLNK, Inc. · 2018 · cites it directly26descendants
K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 2 generations on16descendants
K210133Current Health Monitoring System Gen 2 (G2)Current Health · 2021 · 3 generations on8descendants
K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022 · 3 generations on7descendants
K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l. · 2023 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K003326	Funet Amy Mama Body Thermometer	Funai Radio & Communications Corp.	2001	—
−3	K023956	Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F	Mesure Technology Co., Ltd.	2004	—
−2	K063542	Wireless Temperature Monitor / Models ST323C and ST323F.	Mesure Technology Co., Ltd.	2007	—
−1	K143267	TempTraq TT-100	Blue Spark Technologies, Inc.	2015	—
0 (this device)	K162137	Fever Scout™ Continuous Monitoring thermometer	VivaLNK, Inc.	2017	—
+1	K181013	Fever Scout	VivaLNK, Inc.	2018	—
+2	K191272	Wearable Device, Wearable Package	Current Health, Ltd.	2019	—
+3	K210133	Current Health Monitoring System Gen 2 (G2)	Current Health	2021	—
+3	K221282	Empatica Health Monitoring Platform	Empatica S.r.l.	2022	—
+4	K230457	Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal	Empatica S.r.l.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2019	2	0
2020	2	0
2021	2	0
2022	3	0
2023	5	0
2024	6	0
2025	6	0
2026	2	0

FIG. 1 — Lineage of K162137, 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
*	K143267	TempTraq TT-100 Summary page 5 …batteries, but not to open or modify any other parts of the product. Predicates: TempTraq Model TT-100 by Blue Spark Technologies (K143267) Trade Name: TempTraq Model TT-100 Device Common Name: Armpit thermometer Classification: 21 CFR Sec.…	Blue Spark Technologies, Inc.	2015	—
†	K132761	Wireless Thermometer	Raiing Medical Company	2014	—

Also cleared against K143267: 1 other device →

What descends from it? (29)

See all 29

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K181013	Fever Scout	VivaLNK, Inc.	2018	26
K191620	Vitls Platform	Vitls, Inc.	2020	2
K180767	FEMON Banana Thermometer	Life Science Technology, Inc.	2019	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?

The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K181013 (VivaLNK, Inc., 2018) has gone furthest, with 26 descendants of its own.
1 other device also cites its predicate K143267.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

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 Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for home use. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K162137 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162137: Fever Scout™ Continuous Monitoring thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162137

Report an extraction error

Are you the manufacturer?

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