510(k) · Cleared
ClearedAvita TS8/TS9 Series IR Ear/Forehead Thermometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avita Corporation · FLL Continuous Measurement Thermometer
Cleared on Oct 24, 2003 as substantially equivalent to K010462 (Avita Corporation, 2001) and 1 other predicate after a 164-day review. Its family tree reaches back 1 generation to 2001. 67 later devices descend from it.
- Decided
- Oct 24, 2003
- Review
- 164 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K010462 (2001). 2 ancestors in all. 67 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- This deviceK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- Descendant · cites it directly · 40 of its ownK050463 Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110…Taidoc Technology Corporation · 2005
- Descendant · 2 generations on · 39 of its ownK062445 Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007
- Descendant · 3 generations on · 38 of its ownK081256 Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008
- Descendant · 4 generations on · 37 of its ownK100226 Wireless Body Temperature Monitor Model BTM-Dix Series…Rio Flexon Technology Co., Ltd. · 2010
- Descendant · 5 generations on · 36 of its ownK121696 Wireless ThermometerRaling Medical Company · 2012
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K050463Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110 Ear/Skin/Surface IR…Taidoc Technology Corporation · 2005 · cites it directly40descendants
- K062445Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007 · 2 generations on39descendants
- K081256Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008 · 3 generations on38descendants
- K100226Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H)Rio Flexon Technology Co., Ltd. · 2010 · 4 generations on37descendants
- K121696Wireless ThermometerRaling Medical Company · 2012 · 5 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| 0 (this device) | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| +1 | K050463 | Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110… | Taidoc Technology Corporation | 2005 | — |
| +2 | K062445 | Monitoring Ear Thermometer, Model BTM-D1A | Rio Flexon Technology Co., Ltd. | 2007 | — |
| +3 | K081256 | Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H | Rio Flexon Technology Co., Ltd. | 2008 | — |
| +4 | K100226 | Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) | Rio Flexon Technology Co., Ltd. | 2010 | — |
| +5 | K121696 | Wireless Thermometer | Raling Medical Company | 2012 | — |
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 |
|---|---|---|
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 9 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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? (2)
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.
What descends from it? (67)
See all 673 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K050463 (Taidoc Technology Corporation, 2005) has gone furthest, with 40 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.
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 device is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031503: Avita TS8/TS9 Series IR Ear/Forehead Thermometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031503
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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