510(k) · Cleared
ClearedM5T Instant Fever 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 Aug 1, 2001 after a 16-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Aug 1, 2001
- Review
- 16 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK012217 M5T Instant Fever ThermometerMedisim, Ltd. · 2001
- Descendant · cites it directly · 5 of its ownK032362 UP-Grade Forehead ThermometerMedisim, Ltd. · 2003
- Descendant · 2 generations on · 1 of its ownK103839 Behind Ear Gentle Touch ThermometerKaz, Inc. · 2011
- Descendant · 2 generations on · 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
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K032362UP-Grade Forehead ThermometerMedisim, Ltd. · 2003 · cites it directly5descendants
- K103839Behind Ear Gentle Touch ThermometerKaz, Inc. · 2011 · 2 generations on1descendant
- K070491Digital Forehead Thermometer, Model# KD-2200K-Jump Health Co., Ltd. · 2007 · 2 generations on1descendant
- K051422Dual Mode UP-Grade Forehead/Underarm Thermometer DeviceMedisim, Ltd. · 2005 · cites it directly1descendant
- K131155UGFT3; FHT7Medisim, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012217 | M5T Instant Fever Thermometer | Medisim, Ltd. | 2001 | — |
| +1 | K032362 | UP-Grade Forehead Thermometer | Medisim, Ltd. | 2003 | — |
| +2 | K103839 | Behind Ear Gentle Touch Thermometer | Kaz, Inc. | 2011 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | Up-Grade Thermometer Named without a submission number | |
| * | — | Up-Grade Pro Thermometer Named without a submission number |
What descends from it? (6)
2 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?
- Of its descendants, K032362 (Medisim, Ltd., 2003) has gone furthest, with 5 descendants 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 MS5T is non-sterile, reusable clinical thermometer intended for
the determination of oral, rectal and axillary body temperature
determination in humans.
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/K012217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012217: M5T Instant Fever Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012217
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026