510(k) · Cleared
ClearedFever Scout
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VivaLNK, Inc. · FLL Continuous Measurement Thermometer
Cleared on Aug 21, 2018 as substantially equivalent to K162137 (VivaLNK, Inc., 2017) and 1 other predicate after a 126-day review. Its family tree reaches back 9 generations to 2001. 26 later devices descend from it.
- Decided
- Aug 21, 2018
- Review
- 126 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K010462 (2001). 15 ancestors in all, the oldest K003326 (2001). 26 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 5 generations between
- 3 generations backK121696 Wireless ThermometerRaling Medical Company · 2012
- 2 generations backK132761 Wireless ThermometerRaiing Medical Company · 2014
- 1 generation backK160306 Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. · 2016
- This deviceK181013 Fever ScoutVivaLNK, Inc. · 2018
- Descendant · cites it directly · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
- Descendant · 2 generations on · 8 of its ownK210133 Current Health Monitoring System Gen 2 (G2)Current Health · 2021
- Descendant · 2 generations on · 7 of its ownK221282 Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022
- Descendant · 3 generations on · 4 of its ownK230457 Empatica Health Monitoring Platform; EmbracePlus; Empatica Care…Empatica S.r.l. · 2023
- Descendant · cites it directly · 3 of its ownK203208 Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2022
Show all 9 generations
- Root · 9 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 8 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 7 generations backK050463 Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110…Taidoc Technology Corporation · 2005
- 6 generations backK062445 Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007
- 5 generations backK081256 Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008
- 4 generations backK100226 Wireless Body Temperature Monitor Model BTM-Dix Series…Rio Flexon Technology Co., Ltd. · 2010
- 3 generations backK121696 Wireless ThermometerRaling Medical Company · 2012
- 2 generations backK132761 Wireless ThermometerRaiing Medical Company · 2014
- 1 generation backK160306 Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. · 2016
- This deviceK181013 Fever ScoutVivaLNK, Inc. · 2018
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · cites it directly16descendants
- K210133Current Health Monitoring System Gen 2 (G2)Current Health · 2021 · 2 generations on8descendants
- K221282Empatica Health Monitoring PlatformEmpatica S.r.l. · 2022 · 2 generations on7descendants
- K230457Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care PortalEmpatica S.r.l. · 2023 · 3 generations on4descendants
- K203208Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc. · 2022 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −8 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −7 | K050463 | Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110… | Taidoc Technology Corporation | 2005 | — |
| −6 | K062445 | Monitoring Ear Thermometer, Model BTM-D1A | Rio Flexon Technology Co., Ltd. | 2007 | — |
| −5 | K081256 | Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H | Rio Flexon Technology Co., Ltd. | 2008 | — |
| −4 | K100226 | Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) | Rio Flexon Technology Co., Ltd. | 2010 | — |
| −3 | K121696 | Wireless Thermometer | Raling Medical Company | 2012 | — |
| −2 | K132761 | Wireless Thermometer | Raiing Medical Company | 2014 | — |
| −1 | K160306 | Cloud Smart Thermometer | Guangzhou Bosma Technology Co, Ltd. | 2016 | — |
| 0 (this device) | K181013 | Fever Scout | VivaLNK, Inc. | 2018 | — |
| +1 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
| +2 | K210133 | Current Health Monitoring System Gen 2 (G2) | Current Health | 2021 | — |
| +2 | K221282 | Empatica Health Monitoring Platform | Empatica S.r.l. | 2022 | — |
| +3 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | Empatica S.r.l. | 2023 | — |
| +1 | K203208 | Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System | Taiwan Aulisa Medical Devices Technologies, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 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? (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 |
|---|---|---|---|
| * | K162137 | Fever Scout™ Continuous Monitoring thermometerSummary page 4…evice Common Name: Classification: Product Code: Classification Panel: Class: Device Description: Indications for Use: Traditional 510(k) for expanded indications of K162137 VivaLNK Inc. 51 East Campbell Avenue Suite #160 Campbell, CA 95008 USA Phone: 408-868-2898 Christine Kuo July13, 2018 Fever… | 2017 |
| * | K160306 | Cloud Smart ThermometerSummary page 5…ates with the expanded indications adding and a non-invasive and single patient use in the hospital. The expanded indications is comparable to the secondary predicate (K160306) used for household and medical institutions. Device Substantial Equivalent Comparison Technology Characteristics Characteris… | 2016 |
What descends from it? (26)
See all 266 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?
- The line of descent spans 17 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K191272 (Current Health, Ltd., 2019) has gone furthest, with 16 descendants of its own.
- 2 other devices also cite its predicate K162137.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Fever Scout™ Continuous Monitoring thermometer is a non-invasive and re-usable electronic device for
home use and a non-invasive and single patient use in the hospital. 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/K181013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181013: Fever Scout.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181013
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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