510(k) · Cleared
ClearedUGFT3; FHT7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisim, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Aug 28, 2013 as substantially equivalent to K051422 (Medisim, Ltd., 2005) and 2 other predicates after a 126-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Aug 28, 2013
- Review
- 126 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K902624 (1990). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK902624 BD Flexible Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 3 generations backK983887 UP-Grade and UP-Grade ProMedisim, Ltd. · 1999 · Recalled
- 2 generations backK032362 UP-Grade Forehead ThermometerMedisim, Ltd. · 2003
- 1 generation backK051422 Dual Mode UP-Grade Forehead/Underarm Thermometer DeviceMedisim, Ltd. · 2005
- This deviceK131155 UGFT3; FHT7Medisim, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K902624 | BD Flexible Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −3 | K983887 | UP-Grade and UP-Grade Pro | Medisim, Ltd. | 1999 | 1 |
| −2 | K032362 | UP-Grade Forehead Thermometer | Medisim, Ltd. | 2003 | — |
| −1 | K051422 | Dual Mode UP-Grade Forehead/Underarm Thermometer Device | Medisim, Ltd. | 2005 | — |
| 0 (this device) | 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 |
| 2010 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K051422 | Dual Mode UP-Grade Forehead/Underarm Thermometer DeviceSummary page 1…thermometer, § 880.2910 Product Panel: 80 General hospital 3. Substantial equivalent: a. Medisim's Dual Mode Up Grade ForeheadlUnderarm Thermometer, cleared under K05 1422 b. Vicks (KAZ) Behind Ear Thermometer, cleared under K103839 c. NIR Thermometer, cleared under K090386 4. Desc… | 2005 |
| * | K103839 | Behind Ear Gentle Touch ThermometerSummary page 1…3. Substantial equivalent: a. Medisim's Dual Mode Up Grade ForeheadlUnderarm Thermometer, cleared under K05 1422 b. Vicks (KAZ) Behind Ear Thermometer, cleared under K103839 c. NIR Thermometer, cleared under K090386 4. Description of the new device: The UGFT3 is a non-sterile, reusabl… | 2011 |
| * | K090386 | Non-Invasive Infrared (Nir)Summary page 1…ual Mode Up Grade ForeheadlUnderarm Thermometer, cleared under K05 1422 b. Vicks (KAZ) Behind Ear Thermometer, cleared under K103839 c. NIR Thermometer, cleared under K090386 4. Description of the new device: The UGFT3 is a non-sterile, reusable clinical thermometer intended for the dete… | 2010 |
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 23 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 UJGFT3 is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the temple (forehead); and/or underarm (axilia); and/or behind the ear as measurement sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131155: UGFT3; FHT7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131155
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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