510(k) · Cleared
ClearedInfrared Ear Thermometer, Model Irt-21 and Irt-22
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Choice Smart Health Care Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Nov 21, 2006 as substantially equivalent to K010383 (Tenghi Co., Ltd., 2001) after a 20-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Nov 21, 2006
- Review
- 20 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010383 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK010383 Temp ScanTenghi Co., Ltd. · 2001
- This deviceK063291 Infrared Ear Thermometer, Model Irt-21 and Irt-22Choice Smart Health Care Co., Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010383 | Temp Scan | Tenghi Co., Ltd. | 2001 | — |
| 0 (this device) | K063291 | Infrared Ear Thermometer, Model Irt-21 and Irt-22 | Choice Smart Health Care Co., Ltd. | 2006 | — |
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 |
|---|---|---|---|
| * | K010383 | Temp ScanSummary page 3…nfrared Ear Thermometer (IRT-21 and IRT-22) has the same intended use and technological characteristics as the cleared device of Infrared Ear Thermometer (GT-302) (K010383). Various performance testing data which conducted according to ASTM E1965 and ASTM E1104 standards, such as accuracy t… | 2001 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Infrared Ear Thermometer (IRT-21 and IRT-22), designed with infrared technology, is used to measure body temperature from ear canal. Press the ON/OFF button to turn on the power, insert the probe into the ear canal then press the SCAN button to measure the temperature, when you hear a beep sound, the measurement is complete. Infrared Ear Thermometer (IRT-21 and IRT-22) is intended for household and hospital use on people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063291: Infrared Ear Thermometer, Model Irt-21 and Irt-22.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063291
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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