510(k) · Cleared
ClearedElectronic Thermometer (XHF2001, XHF2002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Putian Hanjiang Huafeng Plastic Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Sep 9, 2021 as substantially equivalent to K202791 (Andon Health Co, Ltd., 2021) after a 129-day review. Its family tree reaches back 11 generations to 2001.
- Decided
- Sep 9, 2021
- Review
- 129 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K010462 (2001). 18 ancestors in all, the oldest K943695 (1995). No later device cites it as a predicate yet.
- Root · 11 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 7 generations between
- 3 generations backK152975 VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016
- 2 generations backK180131 Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
- 1 generation backK202791 iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021
- This deviceK211352 Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. · 2021
Show all 11 generations
- Root · 11 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 10 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 9 generations backK050463 Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110…Taidoc Technology Corporation · 2005
- 8 generations backK062445 Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007
- 7 generations backK081256 Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008
- 6 generations backK100226 Wireless Body Temperature Monitor Model BTM-Dix Series…Rio Flexon Technology Co., Ltd. · 2010
- 5 generations backK121696 Wireless ThermometerRaling Medical Company · 2012
- 4 generations backK132761 Wireless ThermometerRaiing Medical Company · 2014
- 3 generations backK152975 VDT985US Vicks SmartTemp ThermometerKaz USA, Inc., A Helen of Troy Company · 2016
- 2 generations backK180131 Vicks RapidRead Digital ThermometerKaz USA, Inc., A Helen of Troy Company · 2018
- 1 generation backK202791 iHealth Clinical Digital ThermometerAndon Health Co, Ltd. · 2021
- This deviceK211352 Electronic Thermometer (XHF2001, XHF2002)Putian Hanjiang Huafeng Plastic Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −10 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −9 | K050463 | Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110… | Taidoc Technology Corporation | 2005 | — |
| −8 | K062445 | Monitoring Ear Thermometer, Model BTM-D1A | Rio Flexon Technology Co., Ltd. | 2007 | — |
| −7 | K081256 | Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H | Rio Flexon Technology Co., Ltd. | 2008 | — |
| −6 | K100226 | Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) | Rio Flexon Technology Co., Ltd. | 2010 | — |
| −5 | K121696 | Wireless Thermometer | Raling Medical Company | 2012 | — |
| −4 | K132761 | Wireless Thermometer | Raiing Medical Company | 2014 | — |
| −3 | K152975 | VDT985US Vicks SmartTemp Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2016 | — |
| −2 | K180131 | Vicks RapidRead Digital Thermometer | Kaz USA, Inc., A Helen of Troy Company | 2018 | — |
| −1 | K202791 | iHealth Clinical Digital Thermometer | Andon Health Co, Ltd. | 2021 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K202791 | iHealth Clinical Digital ThermometerSummary page 4…: Class 2 Product Code: FLL Regulation Number: CFR 880.2910 Review Panel: General Hospital 5. Identification of Predicate Device(s) 510(k) Number: K202791 Product Name: iHealth Clinical Digital Thermometer 1 o… | 2021 |
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 8 companies; a new generation was cleared every 1.8 years on median.
- None of the 18 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 Electronic Thermometer (XHF2001, XHF2002) is intended to measure the body temperature under the arm and to be
used by consumers in household environments for the people of one month of age and above.
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/K211352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211352: Electronic Thermometer (XHF2001, XHF2002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211352
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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