510(k) · Cleared
ClearedRii Infrared Ear Thermometer, Model: TH60N
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 Jun 29, 2010 as substantially equivalent to K070976 (Radiant Innovation, Inc., 2007) after a 56-day review. Its family tree reaches back 6 generations to 2001.
- Decided
- Jun 29, 2010
- Review
- 56 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K011059 (2001). No later device cites it as a predicate yet.
- Root · 6 generations backK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
- 5 generations backK030324 Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc. · 2003
- 4 generations backK040377 Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc. · 2004
- 3 generations backK051269 Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc. · 2005
- 2 generations backK063185 Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc. · 2006
- 1 generation backK070976 Rii Infrared Ear Thermometer, Model TH01BNRadiant Innovation, Inc. · 2007
- This deviceK101253 Rii Infrared Ear Thermometer, Model: TH60NRadiant Innovation, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011059 | Infared Ear Thermometer, Model TH8 Series | Radiant Innovation, Inc. | 2001 | — |
| −5 | K030324 | Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series | Radiant Innovation, Inc. | 2003 | — |
| −4 | K040377 | Rii Infrared Ear Thermometer, Models Thxxn Series | Radiant Innovation, Inc. | 2004 | — |
| −3 | K051269 | Rii Infrared Ear Thermometer, Models TH00XY Series | Radiant Innovation, Inc. | 2005 | — |
| −2 | K063185 | Rii Infrared Ear Thermometer, Models TH5XY Series | Radiant Innovation, Inc. | 2006 | — |
| −1 | K070976 | Rii Infrared Ear Thermometer, Model TH01BN | Radiant Innovation, Inc. | 2007 | — |
| 0 (this device) | K101253 | Rii Infrared Ear Thermometer, Model: TH60N | Radiant Innovation, Inc. | 2010 | — |
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? (1)
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 |
|---|---|---|---|
| * | K070976 | Rii Infrared Ear Thermometer, Model TH01BNSummary page 1…cal Regulation Number: 21 CFR 880:910 3. Current Clearance Device: Radiant Innovation Infrared Ear Thermometer, Models THO1BN (5 10(k)#: K070976), TH5XY series (510(k)#: K063185), THOOXY series (5i0(k)#: K051269), THXXN series (510(k)#: K040377), THI s… | 2007 |
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 9 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population used in the home setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101253 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101253: Rii Infrared Ear Thermometer, Model: TH60N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101253
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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