510(k) · Cleared
ClearedInfrared Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Brav Electronic Technologies Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Mar 2, 2018 as substantially equivalent to K113761 (Famidoc Technology Co., Ltd., 2012) after a 311-day review. Its family tree reaches back 4 generations to 2001. 6 later devices descend from it.
- Decided
- Mar 2, 2018
- Review
- 311 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K010462 (2001). 5 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 3 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 2 generations backK052849 Infrared Thermometer, Fdir-V1Famidoc Technology Co., Ltd. · 2005
- 1 generation backK113761 Infrared ThermometerFamidoc Technology Co., Ltd. · 2012
- This deviceK171214 Infrared ThermometerShenzhen Brav Electronic Technologies Co., Ltd. · 2018
- Descendant · cites it directly · 2 of its ownK182133 Infrared ThermometerShenzhen AOJ Medical Technology Co., Ltd. · 2018
- Descendant · 2 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 · 3 generations on · 0 of its ownK232128 Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)Shenzhen AOJ Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK201600 Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24…Kangfu Medical Equipment Factory · 2021
- Descendant · cites it directly · 0 of its ownK191283 Infrared Thermometer, Breeze modelSuzhou Melodicare Medical Technology Co., Ltd. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182133Infrared ThermometerShenzhen AOJ Medical Technology Co., Ltd. · 2018 · cites it directly2descendants
- K221039Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F…Shenzhen AOJ Medical Technology Co., Ltd. · 2022 · 2 generations on1descendant
- K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)Shenzhen AOJ Medical Technology Co., Ltd. · 2023 · 3 generations on0descendants
- K201600Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27…Kangfu Medical Equipment Factory · 2021 · cites it directly0descendants
- K191283Infrared Thermometer, Breeze modelSuzhou Melodicare Medical Technology Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −3 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −2 | K052849 | Infrared Thermometer, Fdir-V1 | Famidoc Technology Co., Ltd. | 2005 | — |
| −1 | K113761 | Infrared Thermometer | Famidoc Technology Co., Ltd. | 2012 | — |
| 0 (this device) | K171214 | Infrared Thermometer | Shenzhen Brav Electronic Technologies Co., Ltd. | 2018 | — |
| +1 | K182133 | Infrared Thermometer | Shenzhen AOJ Medical Technology Co., Ltd. | 2018 | — |
| +2 | K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E… | Shenzhen AOJ Medical Technology Co., Ltd. | 2022 | — |
| +3 | K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | Shenzhen AOJ Medical Technology Co., Ltd. | 2023 | — |
| +1 | K201600 | Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26… | Kangfu Medical Equipment Factory | 2021 | — |
| +1 | K191283 | Infrared Thermometer, Breeze model | Suzhou Melodicare Medical Technology Co., Ltd. | 2019 | — |
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 | 1 | 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 |
|---|---|---|---|
| * | K113761 | Infrared ThermometerSummary page 4…midoc Technology Co., Ltd. Device: Famidoc Infrared Thermometer Model: FDIR-V2, FDIR-V4, FDIR-V5, FDIR-V6, FDIR-V7, FDIR-V9, FDIR-V9-3, FDIR-V10, FDIR-V15 510(K) Number: K113761 1／7 4. Indications for Use The infrared thermometer is intended fo… | 2012 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K182133 (Shenzhen AOJ Medical Technology Co., Ltd., 2018) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
The infrared thermometer is intended for the measurement and monitoring of human body temperature by doctors or customers in the hospital or at home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171214: 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/K171214
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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