510(k) · Cleared
ClearedTemp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Iweecare Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Feb 17, 2023 as substantially equivalent to K202603 (Iweecare Co., Ltd., 2021) after a 175-day review. Its family tree reaches back 9 generations to 2001. 1 later device descends from it.
- Decided
- Feb 17, 2023
- Review
- 175 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010462 (2001). 11 ancestors in all, the oldest K003326 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 5 generations between
- 3 generations backK121696 Wireless ThermometerRaling Medical Company · 2012
- 2 generations backK132761 Wireless ThermometerRaiing Medical Company · 2014
- 1 generation backK202603 Temp PalIweecare Co., Ltd. · 2021
- This deviceK222588 Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1Iweecare Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK240333 Wearable Digital Thermometer (T31)Guangdong Genial Technology Co., Ltd. · 2024
Show all 9 generations
- Root · 9 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 8 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 7 generations backK050463 Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110…Taidoc Technology Corporation · 2005
- 6 generations backK062445 Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007
- 5 generations backK081256 Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008
- 4 generations backK100226 Wireless Body Temperature Monitor Model BTM-Dix Series…Rio Flexon Technology Co., Ltd. · 2010
- 3 generations backK121696 Wireless ThermometerRaling Medical Company · 2012
- 2 generations backK132761 Wireless ThermometerRaiing Medical Company · 2014
- 1 generation backK202603 Temp PalIweecare Co., Ltd. · 2021
- This deviceK222588 Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1Iweecare Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K240333Wearable Digital Thermometer (T31)Guangdong Genial Technology Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −8 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −7 | K050463 | Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110… | Taidoc Technology Corporation | 2005 | — |
| −6 | K062445 | Monitoring Ear Thermometer, Model BTM-D1A | Rio Flexon Technology Co., Ltd. | 2007 | — |
| −5 | K081256 | Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H | Rio Flexon Technology Co., Ltd. | 2008 | — |
| −4 | K100226 | Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) | Rio Flexon Technology Co., Ltd. | 2010 | — |
| −3 | K121696 | Wireless Thermometer | Raling Medical Company | 2012 | — |
| −2 | K132761 | Wireless Thermometer | Raiing Medical Company | 2014 | — |
| −1 | K202603 | Temp Pal | Iweecare Co., Ltd. | 2021 | — |
| 0 (this device) | K222588 | Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 | Iweecare Co., Ltd. | 2023 | — |
| +1 | K240333 | Wearable Digital Thermometer (T31) | Guangdong Genial Technology Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K202603 | Temp PalSummary page 4…cate Device Name: Temp Pal Model Number: STP-MB01-1 510(k) Number: K202603 Manufacturer: iWEECARE Co., Ltd. Regulation Number: 88… | 2021 |
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 |
|---|---|---|---|
| K240333 | Wearable Digital Thermometer (T31) | 2024 | 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 22 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K240333 (Guangdong Genial Technology Co., Ltd., 2024) 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. 2023, 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?
Temp Pal is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is reusable and intended for armpit temperature monitoring for persons of all age. The temperature data of device is not intended to replace the advice, diagnosis, nor treatment recommendations of doctor. Temp Pal can be used at home and healthcare center.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222588: Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222588
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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