510(k) · Cleared
ClearedNon-Contact Forehead Infrared Thermometer, Model DT-8806H, Body Infrared Thermometer, Model DT-8806 and Digital Infrared
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Everbest Machinery Industry Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Jul 6, 2010 as substantially equivalent to K052849 (Famidoc Technology Co., Ltd., 2005) after a 15-day review. Its family tree reaches back 3 generations to 2001. 3 later devices descend from it.
- Decided
- Jul 6, 2010
- Review
- 15 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. 3 later devices descend from it, 2 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 deviceK101736 Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body…Shenzhen Everbest Machinery Industry Co., Ltd. · 2010
- Descendant · cites it directly · 1 of its ownK203170 Infrared Thermometer Models: DT-8806S, DT-8807SShenzhen Everbest Machinery Industry Co., Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK221800 Infrared Thermometer (Model: Y20001, Y20002)Zhangzhou Easepal Medical Science and Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK160358 DT-100Mediana Co., Ltd. · 2017
Most influential descendants
Showing 3 of 3 · See all- K203170Infrared Thermometer Models: DT-8806S, DT-8807SShenzhen Everbest Machinery Industry Co., Ltd. · 2021 · cites it directly1descendant
- K221800Infrared Thermometer (Model: Y20001, Y20002)Zhangzhou Easepal Medical Science and Technology Co., Ltd. · 2022 · 2 generations on0descendants
- K160358DT-100Mediana Co., Ltd. · 2017 · cites it directly0descendants
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) | K101736 | Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body Infrared… | Shenzhen Everbest Machinery Industry Co., Ltd. | 2010 | — |
| +1 | K203170 | Infrared Thermometer Models: DT-8806S, DT-8807S | Shenzhen Everbest Machinery Industry Co., Ltd. | 2021 | — |
| +2 | K221800 | Infrared Thermometer (Model: Y20001, Y20002) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2022 | — |
| +1 | K160358 | DT-100 | Mediana Co., Ltd. | 2017 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 26.8 · 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…or, East Block4, Chegongmiao Anhua Industrial Zone Shenzhen R.R.China Device: Infrared Thermometer, Model :FDIR-V1 It's 510O(K) number is K052849 Code: FDA-001 Version: A/0 Page I of 2 Issuing Date: 2009-8-18… | 2005 |
What descends from it? (3)
2 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 9 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K203170 (Shenzhen Everbest Machinery Industry Co., Ltd., 2021) has gone furthest, with 1 descendant 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. 2010, 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 Model: DT-8806H/DT-8806 Non-contact body infrared thermometer is designed for body surface and forehead temperature measurement for infants and adults without contact to human body. The Digital Infrared Ear Thermometer Model: DT-886 can provide a stable, hear -interference -free reading with each measurement, The digital Infrared Thermometer is intended for the periodic measurement and monitoring of human body temperature, It is…
Read the full statement (339 words)
Infrared Thermometer Model: DT-8806H/DT-8806 Non-contact body infrared thermometer is designed for body surface and forehead temperature measurement for infants and adults without contact to human body. The Digital Infrared Ear Thermometer Model: DT-886 can provide a stable, hear -interference -free reading with each measurement, The digital Infrared Thermometer is intended for the periodic measurement and monitoring of human body temperature, It is intended for use on people of all ages. The Infrared Thermometer can be used by consumers in household environment. It is manufactured in accordance with the ASTM E1965-1 998 Standard specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
Infrared Thermometer Model: DT-8806H/DT-8806/DT-886 is medical instruments, used as an assistant device by normal people to evaluate, by the result of measurement, their decision for the next clinical step in order to protect human's health. The function for measuring. human body's temperature with precision helps detect and observe human states of health, in case of any possible illness.
Infrared Thermometer Model: DT-8806H/DT-8806 is a hand-held, non-sterile, reusable medical device, Use and alcohol swab or cotton tissue moistened with alcohol(70% Isopropyl) to clean, the Digital Infrared Ear thermometer(DT-886) casing and the measuring probe contact body. supplied by internal power. It is used for human beings, and it belongs personal use monitoring device.
Infrared Thermometer Model: DT-8806H/DT-8806 is non-contact device. It can detect the temperature from human's forehead, DT-886 is Digital Infrared Ear thermometer ,lt can detect the temperature from human's ear channel It takes only half second(DT-8806/DT-8806H) and one second(DT-886) for one times measurement.
Valid scientific evidence of product testing reports, software verification, and substantial equivalence are provided to guarantee product function, safety, effectiveness, and biological compatibility, etc.
The thermometer shall be cleaned before and after each use. Cleaning method and information are provided in the instructions for use. ( See Chapter 13)
Do not bite, bend, drop or disassemble this thermometer and do not dispose this thermometer and battery into fire. Keep this thermometer away from direct sunlight, moisture, dirt, extreme temperature while use, store or transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101736 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101736: Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body Infrared Thermometer, Model DT-8806 and Digital Infrared.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101736
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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