510(k) · Cleared
ClearedInfrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen AOJ Medical Technology Co., Ltd. · FLL Continuous Measurement Thermometer
Cleared on Dec 20, 2022 as substantially equivalent to K182133 (Shenzhen AOJ Medical Technology Co., Ltd., 2018) after a 257-day review. Its family tree reaches back 6 generations to 2001. 1 later device descends from it.
- Decided
- Dec 20, 2022
- Review
- 257 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010462 (2001). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 5 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 4 generations backK052849 Infrared Thermometer, Fdir-V1Famidoc Technology Co., Ltd. · 2005
- 3 generations backK113761 Infrared ThermometerFamidoc Technology Co., Ltd. · 2012
- 2 generations backK171214 Infrared ThermometerShenzhen Brav Electronic Technologies Co., Ltd. · 2018
- 1 generation backK182133 Infrared ThermometerShenzhen AOJ Medical Technology Co., Ltd. · 2018
- This deviceK221039 Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D…Shenzhen AOJ Medical Technology Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK232128 Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)Shenzhen AOJ Medical Technology Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K232128Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y)Shenzhen AOJ Medical Technology Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −5 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −4 | K052849 | Infrared Thermometer, Fdir-V1 | Famidoc Technology Co., Ltd. | 2005 | — |
| −3 | K113761 | Infrared Thermometer | Famidoc Technology Co., Ltd. | 2012 | — |
| −2 | K171214 | Infrared Thermometer | Shenzhen Brav Electronic Technologies Co., Ltd. | 2018 | — |
| −1 | K182133 | Infrared Thermometer | Shenzhen AOJ Medical Technology Co., Ltd. | 2018 | — |
| 0 (this device) | K221039 | Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E… | Shenzhen AOJ Medical Technology Co., Ltd. | 2022 | — |
| +1 | K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | Shenzhen AOJ Medical Technology Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K182133 | Infrared ThermometerSummary page 4…Name: 21 CFR 880.2910 Clinical Electronic Thermometers Product code: FLL Regulatory Class: Class II Shenzhen AOJ Medical Technology Co., Ltd. AOJ-20A cleared under K182133. The predicate has not been subject to any recall. The AOJ-20 series Infrared thermometer is a handheld device, which can measur… | 2018 |
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 |
|---|---|---|---|
| K232128 | Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) | 2023 | 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 21 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K232128 (Shenzhen AOJ Medical Technology Co., Ltd., 2023) has gone furthest, with 0 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. 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 is intended to measure human body temperature of people over three months old from the eardrum or forehead. It is indicated to be used in homecare and healthcare environments.
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/K221039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221039: Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221039
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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