510(k) · Cleared
ClearediHealth Wireless No-Touch Forehead Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andon Health Co, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Mar 8, 2021 as substantially equivalent to K200531 (Andon Health Co, Ltd., 2020) after a 168-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Mar 8, 2021
- Review
- 168 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K011059 (2001). 12 ancestors in all, the oldest K011291 (2001). No later device cites it as a predicate yet.
- Root · 8 generations backK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
- 7 generations backK030324 Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 SeriesRadiant Innovation, Inc. · 2003
- 6 generations backK040377 Rii Infrared Ear Thermometer, Models Thxxn SeriesRadiant Innovation, Inc. · 2004
- 5 generations backK051269 Rii Infrared Ear Thermometer, Models TH00XY SeriesRadiant Innovation, Inc. · 2005
- 4 generations backK063185 Rii Infrared Ear Thermometer, Models TH5XY SeriesRadiant Innovation, Inc. · 2006
- 3 generations backK162083 RII Multi-function Infrared Thermometer, Model TH52ZRadiant Innovation, Inc. · 2017
- 2 generations backK191570 Infrared Thermometer Model MD-H30Guangzhou Berrcom Medical Device Co., Ltd. · 2019
- 1 generation backK200531 iHealth Infrared No-Touch Forehead ThermometerAndon Health Co, Ltd. · 2020
- This deviceK202753 iHealth Wireless No-Touch Forehead ThermometerAndon Health Co, Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011059 | Infared Ear Thermometer, Model TH8 Series | Radiant Innovation, Inc. | 2001 | — |
| −7 | K030324 | Radiant Innovation Inc. Infrared Ear Thermometer, Models TH1 Series | Radiant Innovation, Inc. | 2003 | — |
| −6 | K040377 | Rii Infrared Ear Thermometer, Models Thxxn Series | Radiant Innovation, Inc. | 2004 | — |
| −5 | K051269 | Rii Infrared Ear Thermometer, Models TH00XY Series | Radiant Innovation, Inc. | 2005 | — |
| −4 | K063185 | Rii Infrared Ear Thermometer, Models TH5XY Series | Radiant Innovation, Inc. | 2006 | — |
| −3 | 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 | K200531 | iHealth Infrared No-Touch Forehead Thermometer | Andon Health Co, Ltd. | 2020 | — |
| 0 (this device) | K202753 | iHealth Wireless No-Touch Forehead Thermometer | Andon Health Co, Ltd. | 2021 | — |
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 |
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 |
|---|---|---|---|
| * | K200531 | iHealth Infrared No-Touch Forehead ThermometerSummary page 4…ral Hospital 4.0 Predicate device information Manufacturer: Andon Health Co., Ltd Device: iHealth Infrared No-Touch Forehead Thermometer (Model: PT3) 510(k) number: K200531 5.0 Indications for Use The Wireless No-Touch Forehead Thermometer is intended for the intermittent measurement of body tempera… | 2020 |
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 20 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 12 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. 2021, 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 Wireless No-Touch Forehead Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can transmit the temperature to a smart device with Bluetooth and can be used by consumers in the household environment and by healthcare providers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K202753 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202753: iHealth Wireless No-Touch Forehead Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202753
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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