510(k) · Cleared
ClearedFEMON Banana Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Science Technology, Inc. · FLL Continuous Measurement Thermometer
Cleared on Jan 22, 2019 as substantially equivalent to K162137 (VivaLNK, Inc., 2017) after a 305-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Jan 22, 2019
- Review
- 305 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003326 (2001). No later device cites it as a predicate yet.
- Root · 5 generations backK003326 Funet Amy Mama Body ThermometerFunai Radio & Communications Corp. · 2001
- 4 generations backK023956 Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F…Mesure Technology Co., Ltd. · 2004
- 3 generations backK063542 Wireless Temperature Monitor / Models ST323C and ST323F.Mesure Technology Co., Ltd. · 2007
- 2 generations backK143267 TempTraq TT-100Blue Spark Technologies, Inc. · 2015
- 1 generation backK162137 Fever Scout™ Continuous Monitoring thermometerVivaLNK, Inc. · 2017
- This deviceK180767 FEMON Banana ThermometerLife Science Technology, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003326 | Funet Amy Mama Body Thermometer | Funai Radio & Communications Corp. | 2001 | — |
| −4 | K023956 | Thermometer Models ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F | Mesure Technology Co., Ltd. | 2004 | — |
| −3 | K063542 | Wireless Temperature Monitor / Models ST323C and ST323F. | Mesure Technology Co., Ltd. | 2007 | — |
| −2 | K143267 | TempTraq TT-100 | Blue Spark Technologies, Inc. | 2015 | — |
| −1 | K162137 | Fever Scout™ Continuous Monitoring thermometer | VivaLNK, Inc. | 2017 | — |
| 0 (this device) | K180767 | FEMON Banana Thermometer | Life Science Technology, Inc. | 2019 | — |
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 |
|---|---|---|---|
| * | K162137 | Fever Scout™ Continuous Monitoring thermometerSummary page 4…ass II (21 CFR 880.2910), Clinical Electronic Thermometer Product Code: FLL 4. Predicate Device Primary Predicate Device: Fever Scout by VivaLink (K162137) 5. Description: The FEMON Banana Thermometer is a thermometer composed of a body patch to be directly attached to the p… | 2017 |
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 18 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 5 ancestors has a recall.
- 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. 2019, 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 FEMON Banana Thermometer is a battery operated electronic device with intended use of measuring human body temperature. This device is intended for armpit temperature measurement for patients 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/K180767 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180767: FEMON Banana Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180767
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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