510(k) · Cleared
ClearedThermo Tek IR Forehead Thermometer, Model 718F
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saat, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Feb 8, 2001 after a 161-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Feb 8, 2001
- Review
- 161 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK002712 Thermo Tek IR Forehead Thermometer, Model 718FSaat, 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 · 2 generations on · 1 of its ownK051422 Dual Mode UP-Grade Forehead/Underarm Thermometer DeviceMedisim, Ltd. · 2005
- Descendant · cites it directly · 1 of its ownK033077 Easytem Duo, Forehead/Ear Thermometer, Model BT-021Metatech Co., Ltd. · 2004
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · 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 · 2 generations on1descendant
- K033077Easytem Duo, Forehead/Ear Thermometer, Model BT-021Metatech Co., Ltd. · 2004 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002712 | Thermo Tek IR Forehead Thermometer, Model 718F | Saat, 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 | — |
| +2 | K051422 | Dual Mode UP-Grade Forehead/Underarm Thermometer Device | Medisim, Ltd. | 2005 | — |
| +1 | K033077 | Easytem Duo, Forehead/Ear Thermometer, Model BT-021 | Metatech Co., Ltd. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
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?
- 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 | — |
https://510kreport.com/device/K002712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002712: Thermo Tek IR Forehead Thermometer, Model 718F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002712
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026