510(k) · Cleared
ClearedBehind Ear Gentle Touch Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaz, Inc. · FLL Continuous Measurement Thermometer
Cleared on Jun 6, 2011 as substantially equivalent to K032362 (Medisim, Ltd., 2003) after a 158-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.
- Decided
- Jun 6, 2011
- Review
- 158 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K902624 (1990). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK902624 BD Flexible Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 2 generations backK983887 UP-Grade and UP-Grade ProMedisim, Ltd. · 1999 · Recalled
- 1 generation backK032362 UP-Grade Forehead ThermometerMedisim, Ltd. · 2003
- This deviceK103839 Behind Ear Gentle Touch ThermometerKaz, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK131155 UGFT3; FHT7Medisim, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131155UGFT3; FHT7Medisim, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K902624 | BD Flexible Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −2 | K983887 | UP-Grade and UP-Grade Pro | Medisim, Ltd. | 1999 | 1 |
| −1 | K032362 | UP-Grade Forehead Thermometer | Medisim, Ltd. | 2003 | — |
| 0 (this device) | K103839 | Behind Ear Gentle Touch Thermometer | Kaz, Inc. | 2011 | — |
| +1 | K131155 | UGFT3; FHT7 | Medisim, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 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 |
|---|---|---|---|
| * | K032362 | UP-Grade Forehead ThermometerSummary page 2…ehind Ear Gentle Touch Thermometer 4.0 Predicate Device: Up-Grade Forehead Thermometer Medisim Ltd. K032362 5.0 Device Description: The over-the-counter Behind Ear Gentle Touch Thermometer - Models V98O/ BET 1000 is… | 2003 |
| † | K031968 | Cerabien ZR | 2003 |
| † | K101747 | Braun Thermoscan Pro 4000 Series and Braun Thermoscan Irt 4000 Series Model 6021791-Pro… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131155 | UGFT3; FHT7 | 2013 | 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 21 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K131155 (Medisim, Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K032362.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Behind Ear Gentle Touch Thermometer (Models V980/BET 1000) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature using behind the earlobe as the measurement site on people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103839: Behind Ear Gentle Touch Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103839
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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