510(k) · Cleared
ClearedRII Multi-function Infrared Thermometer, Model TH52Z
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 Jan 9, 2017 as substantially equivalent to K063185 (Radiant Innovation, Inc., 2006) and 1 other predicate after a 166-day review. Its family tree reaches back 5 generations to 2001. 14 later devices descend from it.
- Decided
- Jan 9, 2017
- Review
- 166 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K011059 (2001). 9 ancestors in all, the oldest K011291 (2001). 14 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
- 4 generations backK030324 Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc. · 2003
- 3 generations backK040377 Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc. · 2004
- 2 generations backK051269 Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc. · 2005
- 1 generation backK063185 Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc. · 2006
- This deviceK162083 RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017
- Descendant · cites it directly · 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 · 2 generations on · 1 of its ownK213011 Infrared Thermometer (model: E201)Bioland Technology, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK200531 iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd. · 2020
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K191570Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019 · cites it directly8descendants
- 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
- K213011Infrared Thermometer (model: E201)Bioland Technology, Ltd. · 2022 · 2 generations on1descendant
- K200531iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd. · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K011059 | Infared Ear Thermometer, Model TH8 Series | Radiant Innovation, Inc. | 2001 | — |
| −4 | K030324 | Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series | Radiant Innovation, Inc. | 2003 | — |
| −3 | 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 | — |
| −1 | K063185 | Rii Infrared Ear Thermometer, Models TH5XY Series | Radiant Innovation, Inc. | 2006 | — |
| 0 (this device) | K162083 | RII Multi-function Infrared Thermometer, Model TH52Z | Radiant Innovation, Inc. | 2017 | — |
| +1 | 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 | — |
| +2 | K213011 | Infrared Thermometer (model: E201) | Bioland Technology, Ltd. | 2022 | — |
| +2 | K200531 | iHealth Infrared No-Touch Forehead Thermometer | Andon Health Co, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K063185 | Rii Infrared Ear Thermometer, Models TH5XY SeriesSummary page 4…Electronic, Clinical Regulatory Class: II Product Code: FLL Classification Panel: General Hospital 3. Predicate Device : 510(k) #K063185 Device Name: RII, Infrared Ear Thermometer, Model TH520 Common Name: Infrared Thermometer Regulation Numb… | 2006 |
| * | K121428 | Non-Contact Clinical ThermometerSummary page 5…ience-Based TEL:+886 3 5644185 http://www.radiantek.com.tw Industrial Park, HsinChu, Taiwan 300, R.O.C. FAX: +886 3 5644170 510(k) #K121428 Device Name: RII, Non-Contact Clinical Thermometer, Model THB0F Common Name: Infrared Thermometer Regulat… | 2012 |
What descends from it? (14)
See all 143 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?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 1.4 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K191570 (Guangzhou Berrcom Medical Device Co., Ltd., 2019) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K063185.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Multi-function Infrared Thermometer, Model TH52Z is intended for the intermittent measurement of human body temperatures. The device is intended for the use at home by people of all ages including neonates and it can be selected Ear mode or Forehead mode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162083 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162083: RII Multi-function Infrared Thermometer, Model TH52Z.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162083
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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