510(k) · Cleared
ClearedInfrared Thermometer (Model: Y20001, Y20002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhangzhou Easepal Medical Science and Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Dec 14, 2022 as substantially equivalent to K203170 (Shenzhen Everbest Machinery Industry Co., Ltd., 2021) after a 176-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Dec 14, 2022
- Review
- 176 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010462 (2001). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 4 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 3 generations backK052849 Infrared Thermometer, Fdir-V1Famidoc Technology Co., Ltd. · 2005
- 2 generations backK101736 Non-Contact Forehead Infrared Thermometer, Model DT-8806H, Body…Shenzhen Everbest Machinery Industry Co., Ltd. · 2010
- 1 generation backK203170 Infrared Thermometer Models: DT-8806S, DT-8807SShenzhen Everbest Machinery Industry Co., Ltd. · 2021
- This deviceK221800 Infrared Thermometer (Model: Y20001, Y20002)Zhangzhou Easepal Medical Science and Technology Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −4 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −3 | K052849 | Infrared Thermometer, Fdir-V1 | Famidoc Technology Co., Ltd. | 2005 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K203170 | Infrared Thermometer Models: DT-8806S, DT-8807SSummary page 5…Infrared Thermometer Classification Name: Clinical Electronic Thermometer Model names: DT-8806S, DT-8807S 510(k) number: K203170 Review Panel: General Hospital Product Code: FLL Regulation Number: 21 CFR 880.2910 Regulat… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All FLL devicesFLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 (Model: Y20001, Y20002) is intended for the intermittent measurement and monitoring of human body temperature from forehead. The device is indicated for use for people of two months and above at homecare and in hospital.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221800: Infrared Thermometer (Model: Y20001, Y20002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221800
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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