510(k) · Cleared
ClearedNon-Contact Clinical 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 Jul 17, 2012 as substantially equivalent to K072108 (Tecnimed S.R.L., 2007) after a 64-day review. Its family tree reaches back 3 generations to 2001. 20 later devices descend from it.
- Decided
- Jul 17, 2012
- Review
- 64 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011291 (2001). 20 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK011291 Temporalscanner Thermometer, SensortouchExergen Corp. · 2001
- 2 generations backK033790 Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2004
- 1 generation backK072108 Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesTecnimed S.R.L. · 2007
- This deviceK121428 Non-Contact Clinical ThermometerRadiant Innovation, Inc. · 2012
- Descendant · cites it directly · 14 of its ownK162083 RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017
- Descendant · 2 generations on · 8 of its ownK191570 Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019
- Descendant · cites it directly · 3 of its ownK181239 Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK190873 Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd. · 2019
- Descendant · cites it directly · 2 of its ownK173048 No-contact Forehead ThermometerDongguan Simzo Electronic Technology Co., Ltd. · 2018
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K162083RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017 · cites it directly14descendants
- K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019 · 2 generations on8descendants
- K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd. · 2018 · cites it directly3descendants
- K190873Infrared Ear/Forehead ThermometerJoytech Healthcare Co., Ltd. · 2019 · 2 generations on2descendants
- K173048No-contact Forehead ThermometerDongguan Simzo Electronic Technology Co., Ltd. · 2018 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011291 | Temporalscanner Thermometer, Sensortouch | Exergen Corp. | 2001 | — |
| −2 | K033790 | Thermofocus 0800, 0900, 01500 and 0700 Series | Tecnimed S.R.L. | 2004 | — |
| −1 | K072108 | Modification to Thermofocus 0800, 0900, 01500 and 0700 Series | Tecnimed S.R.L. | 2007 | — |
| 0 (this device) | K121428 | Non-Contact Clinical Thermometer | Radiant Innovation, Inc. | 2012 | — |
| +1 | K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | Radiant Innovation, Inc. | 2017 | — |
| +2 | K191570 | Infrared Thermometer Model MD-H30 | Guangzhou Berrcom Medical Device Co., Ltd. | 2019 | — |
| +1 | K181239 | Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer | Joytech Healthcare Co., Ltd. | 2018 | — |
| +2 | K190873 | Infrared Ear/Forehead Thermometer | Joytech Healthcare Co., Ltd. | 2019 | — |
| +1 | K173048 | No-contact Forehead Thermometer | Dongguan Simzo Electronic Technology Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K072108 | Modification to Thermofocus 0800, 0900, 01500 and 0700 SeriesSummary page 1…11 Product Code: FLL Regulation Number: 21CFR 880.2910 3. Predicate Device: TECNIMED sr], Thermofocus 0 1500 series Thermometer.(51I0(k) 4K072108) 4. Device Description: The RhI Non-contact Clinical Thermometer, Model THBOF is electronic thermometer using an… | 2007 |
What descends from it? (20)
See all 205 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | 2017 | 14 |
| K181239 | Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer | 2018 | 3 |
| K173048 | No-contact Forehead Thermometer | 2018 | 2 |
| K240648 | Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) | 2024 | 0 |
| K163601 | RII Smart IR Thermometer | 2018 | 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K162083 (Radiant Innovation, Inc., 2017) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K072108.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Non-contact Clinical Thermometer, Model THBOF is an infrared thermometer intended for
the intermittent measurement of human body temperature in people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121428: Non-Contact Clinical Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121428
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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