510(k) · Cleared
ClearedUP-Grade Forehead Thermometer
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 Dec 4, 2003 as substantially equivalent to K983887 (Medisim, Ltd., 1999) and 3 other predicates after a 126-day review. Its family tree reaches back 2 generations to 1990. 5 later devices descend from it.
- Decided
- Dec 4, 2003
- Review
- 126 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K902624 (1990). 6 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK902624 BD Flexible Digital ThermometerBd Becton Dickinson Vacutainer Systems Preanalytic · 1990
- 1 generation backK983887 UP-Grade and UP-Grade ProMedisim, Ltd. · 1999 · Recalled
- This deviceK032362 UP-Grade Forehead ThermometerMedisim, Ltd. · 2003
- Descendant · cites it directly · 1 of its ownK103839 Behind Ear Gentle Touch ThermometerKaz, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK070491 Digital Forehead Thermometer, Model# KD-2200K-Jump Health Co., Ltd. · 2007
- Descendant · cites it directly · 1 of its ownK051422 Dual Mode UP-Grade Forehead/Underarm Thermometer DeviceMedisim, Ltd. · 2005
- Descendant · 2 generations on · 0 of its ownK131155 UGFT3; FHT7Medisim, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK103617 Digital Forehead ThermometerK-Jump Health Co., Ltd. · 2011 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K103839Behind Ear Gentle Touch ThermometerKaz, Inc. · 2011 · cites it directly1descendant
- K070491Digital Forehead Thermometer, Model# KD-2200K-Jump Health Co., Ltd. · 2007 · cites it directly1descendant
- K051422Dual Mode UP-Grade Forehead/Underarm Thermometer DeviceMedisim, Ltd. · 2005 · cites it directly1descendant
- K131155UGFT3; FHT7Medisim, Ltd. · 2013 · 2 generations on0descendants
- K103617Digital Forehead ThermometerK-Jump Health Co., Ltd. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K902624 | BD Flexible Digital Thermometer | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990 | — |
| −1 | K983887 | UP-Grade and UP-Grade Pro | Medisim, Ltd. | 1999 | 1 |
| 0 (this device) | K032362 | UP-Grade Forehead Thermometer | Medisim, Ltd. | 2003 | — |
| +1 | K103839 | Behind Ear Gentle Touch Thermometer | Kaz, Inc. | 2011 | — |
| +1 | K070491 | Digital Forehead Thermometer, Model# KD-2200 | K-Jump Health Co., Ltd. | 2007 | — |
| +1 | K051422 | Dual Mode UP-Grade Forehead/Underarm Thermometer Device | Medisim, Ltd. | 2005 | — |
| +2 | K131155 | UGFT3; FHT7 | Medisim, Ltd. | 2013 | — |
| +2 | K103617 | Digital Forehead Thermometer | K-Jump Health Co., Ltd. | 2011 | 1 |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K983887 | UP-Grade and UP-Grade ProSummary page 2…ntially equivalent in intended use, technology characteristics, and performance characteristics to the: · UP-Grade Thermometer (Medisim LTD.) cleared under K983887 * M5T Instant Thermometer (Medisim LTD.) cleared under K012217 * Thermoteck (SAAT Ltd.) IR Forehead Thermometer mod… | 1999 |
| * | K012217 | M5T Instant Fever ThermometerSummary page 2…and performance characteristics to the: · UP-Grade Thermometer (Medisim LTD.) cleared under K983887 * M5T Instant Thermometer (Medisim LTD.) cleared under K012217 * Thermoteck (SAAT Ltd.) IR Forehead Thermometer model 718F cleared under K002712. · Scanner (Exergen… | 2001 |
| * | K002712 | Thermo Tek IR Forehead Thermometer, Model 718FSummary page 2…K983887 * M5T Instant Thermometer (Medisim LTD.) cleared under K012217 * Thermoteck (SAAT Ltd.) IR Forehead Thermometer model 718F cleared under K002712. · Scanner (Exergen Co.) Cleared under KO01291. Device Description: The over-the-counter Up-Grade Forehead Th… | 2001 |
| * | K011291 | Temporalscanner Thermometer, Sensortouch Our reading of the summary gave K001291, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words. | 2001 |
What descends from it? (5)
3 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 13 years and passes through 2 companies; a new generation was cleared every 8.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K103839 (Kaz, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 UP-GRADE FOREHEAD THERMOMETER is a non-sterile, reusable clinical thermometer intended for the determination of human's body temperature using the forehead as measurement site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032362: UP-Grade Forehead Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032362
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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