510(k) · Cleared
ClearediHealth Clinical Digital 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 Jan 5, 2021 as substantially equivalent to K180131 (Kaz USA, Inc., A Helen of Troy Company, 2018) after a 105-day review. Its family tree reaches back 10 generations to 2001. 1 later device descends from it.
- Decided
- Jan 5, 2021
- Review
- 105 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010462 (2001). 17 ancestors in all, the oldest K943695 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 6 generations between
- 3 generations backK132761 Wireless ThermometerRaiing Medical Company · 2014
- 2 generations backK152975 VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016
- 1 generation backK180131 Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
- This deviceK202791 iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK211352 Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. · 2021
Show all 10 generations
- Root · 10 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 9 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 8 generations backK050463 Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110…Taidoc Technology Corporation · 2005
- 7 generations backK062445 Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007
- 6 generations backK081256 Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008
- 5 generations backK100226 Wireless Body Temperature Monitor Model BTM-Dix Series…Rio Flexon Technology Co., Ltd. · 2010
- 4 generations backK121696 Wireless ThermometerRaling Medical Company · 2012
- 3 generations backK132761 Wireless ThermometerRaiing Medical Company · 2014
- 2 generations backK152975 VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016
- 1 generation backK180131 Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
- This deviceK202791 iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K211352Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −9 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −8 | K050463 | Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110… | Taidoc Technology Corporation | 2005 | — |
| −7 | K062445 | Monitoring Ear Thermometer, Model BTM-D1A | Rio Flexon Technology Co., Ltd. | 2007 | — |
| −6 | K081256 | Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H | Rio Flexon Technology Co., Ltd. | 2008 | — |
| −5 | K100226 | Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) | Rio Flexon Technology Co., Ltd. | 2010 | — |
| −4 | K121696 | Wireless Thermometer | Raling Medical Company | 2012 | — |
| −3 | K132761 | Wireless Thermometer | Raiing Medical Company | 2014 | — |
| −2 | K152975 | VDT985US Vicks SmartTemp Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2016 | — |
| −1 | K180131 | Vicks RapidRead Digital Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2018 | — |
| 0 (this device) | K202791 | iHealth Clinical Digital Thermometer | Andon Health Co, Ltd. | 2021 | — |
| +1 | K211352 | Electronic Thermometer (XHF2001, XHF2002) | Putian Hanjiang Huafeng Plastic Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K180131 | Vicks RapidRead Digital ThermometerSummary page 4…General Hospital 4.0 Predicate device information Manufacturer: Kaz USA, Inc., A Helen of Troy Company Device: Vicks RapidRead Digital Thermometer 510(k) number: K180131 5.0 Intended use The Clinical Digital Thermometer is intended to measure the body temperature oral or axillaries (under the arm… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211352 | Electronic Thermometer (XHF2001, XHF2002) | 2021 | 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 20 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K211352 (Putian Hanjiang Huafeng Plastic Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
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 Clinical Digital Thermometer is intended to measure the body temperature oral or axillaries (under the arm) and to be used by consumers in household environments. It is intended for use on adults and children ages 4 and up.
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/K202791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202791: iHealth Clinical Digital Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202791
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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