510(k) · Cleared
ClearedInfared Ear Thermometer, Model TH8 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiant Innovation, Inc. · FLL Continuous Measurement Thermometer
Cleared on Sep 17, 2001 after a 164-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it.
- Decided
- Sep 17, 2001
- Review
- 164 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 8 citing it directly.
- This deviceK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
- Descendant · cites it directly · 21 of its ownK030324 Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc. · 2003
- Descendant · cites it directly · 20 of its ownK040377 Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc. · 2004
- Descendant · 2 generations on · 19 of its ownK051269 Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc. · 2005
- Descendant · 3 generations on · 18 of its ownK063185 Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc. · 2006
- Descendant · cites it directly · 16 of its ownK101264 Tempus IC Professional Patient MonitorRemote Diagnostic Technologies, Ltd. · 2010 · Recalled
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K030324Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc. · 2003 · cites it directly21descendants
- K040377Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc. · 2004 · cites it directly20descendants
- K051269Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc. · 2005 · 2 generations on19descendants
- K063185Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc. · 2006 · 3 generations on18descendants
- K101264Tempus IC Professional Patient MonitorRemote Diagnostic Technologies, Ltd. · 2010 · cites it directly16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011059 | Infared Ear Thermometer, Model TH8 Series | Radiant Innovation, Inc. | 2001 | — |
| +1 | K030324 | Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series | Radiant Innovation, Inc. | 2003 | — |
| +1 | K040377 | Rii Infrared Ear Thermometer, Models Thxxn Series | Radiant Innovation, Inc. | 2004 | — |
| +2 | K051269 | Rii Infrared Ear Thermometer, Models TH00XY Series | Radiant Innovation, Inc. | 2005 | — |
| +3 | K063185 | Rii Infrared Ear Thermometer, Models TH5XY Series | Radiant Innovation, Inc. | 2006 | — |
| +1 | K101264 | Tempus IC Professional Patient Monitor | Remote Diagnostic Technologies, Ltd. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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? (48)
See all 488 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030324 | Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series | 2003 | 21 |
| K040377 | Rii Infrared Ear Thermometer, Models Thxxn Series | 2004 | 20 |
| K101264 | Tempus IC Professional Patient Monitor | 2010 | 16 |
| K103097 | Infrared Ear Thermometer | 2010 | 4 |
| K081788 | Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200 | 2008 | 1 |
| K180387 | Infrared Ear Thermometer | 2019 | 0 |
| K102187 | Rii Infrared Ear Thermometer, | 2010 | 0 |
| K020504 | Infrared Ear Thermometer, Models TH88 Series | 2002 | 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?
- Of its descendants, K030324 (Radiant Innovation, Inc., 2003) has gone furthest, with 21 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/K011059 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011059: Infared Ear Thermometer, Model TH8 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011059
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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