510(k) · Cleared
ClearedInfrared Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Famidoc Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Sep 7, 2012 as substantially equivalent to K052849 (Famidoc Technology Co., Ltd., 2005) after a 261-day review. Its family tree reaches back 3 generations to 2001. 7 later devices descend from it.
- Decided
- Sep 7, 2012
- Review
- 261 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010462 (2001). 4 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 2 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 1 generation backK052849 Infrared Thermometer, Fdir-V1Famidoc Technology Co., Ltd. · 2005
- This deviceK113761 Infrared ThermometerFamidoc Technology Co., Ltd. · 2012
- Descendant · cites it directly · 6 of its ownK171214 Infrared ThermometerShenzhen Brav Electronic Technologies Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK182133 Infrared ThermometerShenzhen AOJ Medical Technology Co., Ltd. · 2018
- Descendant · 3 generations on · 1 of its ownK221039 Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D…Shenzhen AOJ Medical Technology Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK232128 Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)Shenzhen AOJ Medical Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK201600 Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24…Kangfu Medical Equipment Factory · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K171214Infrared ThermometerShenzhen Brav Electronic Technologies Co., Ltd. · 2018 · cites it directly6descendants
- K182133Infrared ThermometerShenzhen AOJ Medical Technology Co., Ltd. · 2018 · 2 generations on2descendants
- K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F…Shenzhen AOJ Medical Technology Co., Ltd. · 2022 · 3 generations on1descendant
- K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)Shenzhen AOJ Medical Technology Co., Ltd. · 2023 · 4 generations on0descendants
- K201600Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27…Kangfu Medical Equipment Factory · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −2 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −1 | K052849 | Infrared Thermometer, Fdir-V1 | Famidoc Technology Co., Ltd. | 2005 | — |
| 0 (this device) | K113761 | Infrared Thermometer | Famidoc Technology Co., Ltd. | 2012 | — |
| +1 | K171214 | Infrared Thermometer | Shenzhen Brav Electronic Technologies Co., Ltd. | 2018 | — |
| +2 | K182133 | Infrared Thermometer | Shenzhen AOJ Medical Technology Co., Ltd. | 2018 | — |
| +3 | K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E… | Shenzhen AOJ Medical Technology Co., Ltd. | 2022 | — |
| +4 | K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | Shenzhen AOJ Medical Technology Co., Ltd. | 2023 | — |
| +2 | K201600 | Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26… | Kangfu Medical Equipment Factory | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K052849 | Infrared Thermometer, Fdir-V1Summary page 1…Device Information Sponsor: Famidoc Technology Co., Ltd. Device: Infrared Thermometer, model EDIR-Vi 510(K) Number: K052849 Chapter 7, Page 1 of 3 S… | 2005 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171214 | Infrared Thermometer | 2018 | 6 |
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 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K171214 (Shenzhen Brav Electronic Technologies Co., Ltd., 2018) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K052849.
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?
Famidoc Infrared Thermometers, models: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FOIR-ViO, FDIR-V15, are intended for intermittent measurement and monitoring of human body temperature by consumers in the home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113761 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113761: Infrared Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113761
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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