510(k) · Cleared
ClearedInfrared Thermometer, Fdir-V1
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 Oct 26, 2005 as substantially equivalent to K031503 (Avita Corporation, 2003) after a 15-day review. Its family tree reaches back 2 generations to 2001. 24 later devices descend from it.
- Decided
- Oct 26, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010462 (2001). 3 ancestors in all. 24 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 1 generation backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- This deviceK052849 Infrared Thermometer, Fdir-V1Famidoc Technology Co., Ltd. · 2005
- Descendant · cites it directly · 9 of its ownK080759 Thermoflash LX-26Jxb Co. Ltd Guangzhou (China) · 2008
- Descendant · 2 generations on · 8 of its ownK102947 Non-Contact Infrared ThermometerK-Jump Health Co., Ltd. · 2011
- Descendant · cites it directly · 7 of its ownK113761 Infrared ThermometerFamidoc Technology Co., Ltd. · 2012
- Descendant · 2 generations on · 6 of its ownK171214 Infrared ThermometerShenzhen Brav Electronic Technologies Co., Ltd. · 2018
- Descendant · 3 generations on · 5 of its ownK131243 Non-Contact Infrared ThermometerShenzhen Jumper Medical Equipment Co., Ltd. · 2013
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K080759Thermoflash LX-26Jxb Co. Ltd Guangzhou (China) · 2008 · cites it directly9descendants
- K102947Non-Contact Infrared ThermometerK-Jump Health Co., Ltd. · 2011 · 2 generations on8descendants
- K113761Infrared ThermometerFamidoc Technology Co., Ltd. · 2012 · cites it directly7descendants
- K171214Infrared ThermometerShenzhen Brav Electronic Technologies Co., Ltd. · 2018 · 2 generations on6descendants
- K131243Non-Contact Infrared ThermometerShenzhen Jumper Medical Equipment Co., Ltd. · 2013 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −1 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| 0 (this device) | K052849 | Infrared Thermometer, Fdir-V1 | Famidoc Technology Co., Ltd. | 2005 | — |
| +1 | K080759 | Thermoflash LX-26 | Jxb Co. Ltd Guangzhou (China) | 2008 | — |
| +2 | K102947 | Non-Contact Infrared Thermometer | K-Jump Health Co., Ltd. | 2011 | — |
| +1 | K113761 | Infrared Thermometer | Famidoc Technology Co., Ltd. | 2012 | — |
| +2 | K171214 | Infrared Thermometer | Shenzhen Brav Electronic Technologies Co., Ltd. | 2018 | — |
| +3 | K131243 | Non-Contact Infrared Thermometer | Shenzhen Jumper Medical Equipment Co., Ltd. | 2013 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 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 |
|---|---|---|---|
| * | K031503 | Avita TS8/TS9 Series IR Ear/Forehead ThermometerSummary page 2…frared Thermometer Model FDIR-V1 is substantially equivalent to AVITA 3 in 1 Ear/Forehead/Room Thermometer for the TS8 Series Model TS-802, It's 510(k) number is K031503. The two device are very similar in design principle, intended use, functions, material and the adopting applicable stand… | 2003 |
What descends from it? (24)
See all 245 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080759 | Thermoflash LX-26 | 2008 | 9 |
| K113761 | Infrared Thermometer | 2012 | 7 |
| K101736 | Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body Infrared Thermometer… | 2010 | 3 |
| K161933 | The Braun ThermoScan® 3 High Speed Compact Ear Thermometer | 2016 | 0 |
| K100488 | IR Ear/Forehead Thermometer Mode DX6635, DX6637, DTH1081 | 2010 | 0 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K080759 (Jxb Co. Ltd Guangzhou (China), 2008) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K031503.
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?
The device is intended for the 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/K052849 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052849: Infrared Thermometer, Fdir-V1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052849
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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