510(k) · Cleared
ClearedThermoclick
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
T&R BIOFAB CO., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Dec 5, 2023 as substantially equivalent to K211776 (Microlife Intellectual Property GmbH, 2022) after a 511-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Dec 5, 2023
- Review
- 511 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000969 (2000). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK000969 Microlife Digital Infrared Ear Thermometer, Model IR1DA1Microlife Corp. · 2000
- 5 generations backK020725 Microlife Digital Infrared Ear Thermometer, Model IR1DE1Microlife Corp. · 2002
- 4 generations backK033820 Microlife Digital Infrared Forehead Thermometer, Model FR1DM1Microlife Intellectual Property GmbH · 2004
- 3 generations backK100953 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1Microlife Intellectual Property GmbH · 2010
- 2 generations backK191829 Microlife Non-Contact Infrared Forehead ThermometerMicrolife Intellectual Property GmbH · 2020
- 1 generation backK211776 Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B…Microlife Intellectual Property GmbH · 2022
- This deviceK222057 ThermoclickT&R BIOFAB CO., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000969 | Microlife Digital Infrared Ear Thermometer, Model IR1DA1 | Microlife Corp. | 2000 | — |
| −5 | K020725 | Microlife Digital Infrared Ear Thermometer, Model IR1DE1 | Microlife Corp. | 2002 | — |
| −4 | K033820 | Microlife Digital Infrared Forehead Thermometer, Model FR1DM1 | Microlife Intellectual Property GmbH | 2004 | — |
| −3 | K100953 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1DZ1 | Microlife Intellectual Property GmbH | 2010 | — |
| −2 | K191829 | Microlife Non-Contact Infrared Forehead Thermometer | Microlife Intellectual Property GmbH | 2020 | — |
| −1 | K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) | Microlife Intellectual Property GmbH | 2022 | — |
| 0 (this device) | K222057 | Thermoclick | T&R BIOFAB CO., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT)Summary page 6…nloaded/installed from each app store. Predicate Device • Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) - 510(k) Number: K211776 - Regulation Name: Clinical Electronic Thermometer - Device Class: II - Product Code: FLL - Regulatio… | 2022 |
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 23 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 10 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. 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?
The THERMOCLICK is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home. The device can be used in connection with a smart phone running the THERMOCLICK Mobile Application. The memory data can be transferred to the smart phone via Bluetooth.
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/K222057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222057: Thermoclick.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222057
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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