510(k) · Cleared
ClearedInfrared Ear Therometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fudakang Industrial Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Mar 29, 2012 as substantially equivalent to K081788 (Innochips Technology Co., Ltd., 2008) and 1 other predicate after a 286-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Mar 29, 2012
- Review
- 286 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011059 (2001). 4 ancestors in all, the oldest K011291 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK011059 Infared Ear Thermometer, Model TH8 SeriesRadiant Innovation, Inc. · 2001
- 1 generation backK081788 Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200Innochips Technology Co., Ltd. · 2008
- This deviceK111703 Infrared Ear TherometerFudakang Industrial Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011059 | Infared Ear Thermometer, Model TH8 Series | Radiant Innovation, Inc. | 2001 | — |
| −1 | K081788 | Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200 | Innochips Technology Co., Ltd. | 2008 | — |
| 0 (this device) | K111703 | Infrared Ear Therometer | Fudakang Industrial Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K081788 | Infrared Ear Thermometer, Models Innotherm Ict-100 and Ict-200Summary page 1…nical Electronic Thermometer/I Infrared Ear Thermometer 2. Equivalent legally marketed device: This product is similar in design and identical in function to the K081788/ INFARED EAR THERMOMETER, MODEL: InnoTherm lCT-l00 / INNOCHIPS TECHNOLOGY Co., Ltd. and THE INFRARED FOREHEAD THERMOMETE… | 2008 |
| * | K101912 | The Infrared Forehead Thermometer, Model FS-300&301Summary page 1…ction to the K081788/ INFARED EAR THERMOMETER, MODEL: InnoTherm lCT-l00 / INNOCHIPS TECHNOLOGY Co., Ltd. and THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301(K1 01912)!/ HUBDIC CO., LTD 3. Indications for Use (intended use): Infrared Thermometer (FT-F1 1) is intended for an electronic clini… | 2010 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 4 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. 2012, 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?
Infrared Thermometer (FT-F11) is intended for an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in the neonatal, pediatric and adult population.
Infrared Thermometer, (FT-F21, FT-F31, FT-F41) is intended for intermittent measurement of human body temperature in people of all ages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111703 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111703: Infrared Ear Therometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111703
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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