510(k) · Cleared
ClearedFora Diamond Nexus Mini Infrared Forehead Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocare Asia Corporation, Ltd. · FLL Continuous Measurement Thermometer
Cleared on Feb 21, 2014 as substantially equivalent to K113159 (Taidoc Technology Corporation, 2012) after a 199-day review. Its family tree reaches back 3 generations to 2006.
- Decided
- Feb 21, 2014
- Review
- 199 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K061800 (2006). No later device cites it as a predicate yet.
- Root · 3 generations backK061800 Clever TD-1112 Ear/Skin/Surface IR ThermometerTaidoc Technology Corporation · 2006
- 2 generations backK081445 Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261BTaidoc Technology Corporation · 2008
- 1 generation backK113159 U-Right TD-1240 ThermometerTaidoc Technology Corporation · 2012
- This deviceK132457 Fora Diamond Nexus Mini Infrared Forehead ThermometerBiocare Asia Corporation, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K061800 | Clever TD-1112 Ear/Skin/Surface IR Thermometer | Taidoc Technology Corporation | 2006 | — |
| −2 | K081445 | Fora Comfortscan Ear Thermometer, Models TD-1261A; TD-1261B | Taidoc Technology Corporation | 2008 | — |
| −1 | K113159 | U-Right TD-1240 Thermometer | Taidoc Technology Corporation | 2012 | — |
| 0 (this device) | K132457 | Fora Diamond Nexus Mini Infrared Forehead Thermometer | Biocare Asia Corporation, Ltd. | 2014 | — |
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 |
|---|---|---|---|
| * | K113159 | U-Right TD-1240 ThermometerSummary page 1…hermometer Classification Panel: General Hospital (80) Device Classification: Class 11 3. Predicate Device The predicate device is URIGHT TD- 1240 Thermometer (K113159) marketed by TaiDoc Technology Corporation. 4. Device Description FORA Diamond Nexus Mini Infrared Forehead Thermometer is c… | 2012 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K113159.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
FORA Diamond Nexus Mini Infrared Forehead Thermometer is intended for the intermittent measurement and monitoring of human body temperature from forehead measurement at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132457: Fora Diamond Nexus Mini Infrared 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/K132457
Report an extraction error
Are you the manufacturer?
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