510(k) · Cleared
ClearedRII Smart IR Thermometer
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 Dec 6, 2018 as substantially equivalent to K121428 (Radiant Innovation, Inc., 2012) after a 715-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Dec 6, 2018
- Review
- 715 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011291 (2001). No later device cites it as a predicate yet.
- Root · 4 generations backK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
- 3 generations backK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
- 2 generations backK072108 Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2007
- 1 generation backK121428 Non-Contact Clinical ThermometerRadiant Innovation, Inc. · 2012
- This deviceK163601 RII Smart IR ThermometerRadiant Innovation, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011291 | Temporalscanner Thermometer, Sensortouch | Exergen Corp. | 2001 | — |
| −3 | K033790 | Thermofocus 0800, 0900, 01500 and 0700 Series | Tecnimed S.R.L. | 2004 | — |
| −2 | K072108 | Modification to Thermofocus 0800, 0900, 01500 and 0700 Series | Tecnimed S.R.L. | 2007 | — |
| −1 | K121428 | Non-Contact Clinical Thermometer | Radiant Innovation, Inc. | 2012 | — |
| 0 (this device) | K163601 | RII Smart IR Thermometer | Radiant Innovation, Inc. | 2018 | — |
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 |
|---|---|---|---|
| * | K121428 | Non-Contact Clinical ThermometerSummary page 4…er Regulatory Class: II Product Code: FLL Classification Panel: General Hospital 3. Predicate Device : Primary predicate: 510(k) #K121428 Device Name: RII, Non-Contact Clinical Thermometer, Model THB0F Common Name: Infrared Thermometer Regulat… | 2012 |
| † | K132514 | Kinsa Smart Thermometer | 2013 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 4 ancestors has a recall.
- 4 other devices also cite its predicate K121428.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 RII Smart IR Thermometer, Model TMS-01A is a non-contact infrared forehead thermometer and can only be used
with an APP since the display only on a device with the APP. It is intended for the intermittent measurement of human
body temperatures and is to be used at home for people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163601 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163601: RII Smart IR Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163601
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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