510(k) · Cleared
ClearedInfrared Thermometer Models: DT-8806S, DT-8807S
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 Apr 16, 2021 as substantially equivalent to K101736 (Shenzhen Everbest Machinery Industry Co., Ltd., 2010) after a 175-day review. Its family tree reaches back 4 generations to 2001. 1 later device descends from it.
- Decided
- Apr 16, 2021
- Review
- 175 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. 1 later device descends from it, 1 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 backK101736 Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body…Shenzhen Everbest Machinery Industry Co., Ltd. · 2010
- This deviceK203170 Infrared Thermometer Models: DT-8806S, DT-8807SShenzhen Everbest Machinery Industry Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK221800 Infrared Thermometer (Model: Y20001, Y20002)Zhangzhou Easepal Medical Science and Technology Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221800Infrared Thermometer (Model: Y20001, Y20002)Zhangzhou Easepal Medical Science and Technology Co., Ltd. · 2022 · 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 | K101736 | Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body Infrared… | Shenzhen Everbest Machinery Industry Co., Ltd. | 2010 | — |
| 0 (this device) | K203170 | Infrared Thermometer Models: DT-8806S, DT-8807S | Shenzhen Everbest Machinery Industry Co., Ltd. | 2021 | — |
| +1 | K221800 | Infrared Thermometer (Model: Y20001, Y20002) | Zhangzhou Easepal Medical Science and Technology Co., Ltd. | 2022 | — |
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 |
|---|---|---|
| 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 26.7 · 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 |
|---|---|---|---|
| * | K101736 | Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body Infrared Thermometer…Summary page 7…device, Infrared Thermometer, Models: DT-8806S, DT-8807S is substantially equivalent to the Infrared Thermometer, Models: DT-8806, DT-8806H cleared under K101736 SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD. Page 4 4 | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221800 | Infrared Thermometer (Model: Y20001, Y20002) | 2022 | 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 20 years and passes through 3 companies; a new generation was cleared every 4.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K221800 (Zhangzhou Easepal Medical Science and Technology Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K101736.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 intermittent measurement of human body temperature from
forehead for people of all ages. The device is reusable for home use and clinical use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203170 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203170: Infrared Thermometer Models: DT-8806S, DT-8807S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203170
Report an extraction error
Are you the manufacturer?
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