510(k) · Cleared
ClearedAION TempShield™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aion Biosystems, Inc. · FLL Continuous Measurement Thermometer
Cleared on Mar 14, 2025 as substantially equivalent to K232010 (Aion Biosystems, Inc., 2023) and 1 other predicate after a 30-day review. Its family tree reaches back 12 generations to 2001.
- Decided
- Mar 14, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- FLL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K010462 (2001). 18 ancestors in all, the oldest K003326 (2001). No later device cites it as a predicate yet.
- Root · 12 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 8 generations between
- 3 generations backK181013 Fever ScoutVivaLNK, Inc. · 2018
- 2 generations backK203215 Radius T wearable thermometerMasimo Corporation · 2021
- 1 generation backK232010 iTEMPSHIELDAion Biosystems, Inc. · 2023
- This deviceK250401 AION TempShield™Aion Biosystems, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK010462 Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series)Avita Corporation · 2001
- 11 generations backK031503 Avita TS8/TS9 Series IR Ear/Forehead ThermometerAvita Corporation · 2003
- 10 generations backK050463 Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110…Taidoc Technology Corporation · 2005
- 9 generations backK062445 Monitoring Ear Thermometer, Model BTM-D1ARio Flexon Technology Co., Ltd. · 2007
- 8 generations backK081256 Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and HRio Flexon Technology Co., Ltd. · 2008
- 7 generations backK100226 Wireless Body Temperature Monitor Model BTM-Dix Series…Rio Flexon Technology Co., Ltd. · 2010
- 6 generations backK121696 Wireless ThermometerRaling Medical Company · 2012
- 5 generations backK132761 Wireless ThermometerRaiing Medical Company · 2014
- 4 generations backK160306 Cloud Smart ThermometerGuangzhou Bosma Technology Co, Ltd. · 2016
- 3 generations backK181013 Fever ScoutVivaLNK, Inc. · 2018
- 2 generations backK203215 Radius T wearable thermometerMasimo Corporation · 2021
- 1 generation backK232010 iTEMPSHIELDAion Biosystems, Inc. · 2023
- This deviceK250401 AION TempShield™Aion Biosystems, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K010462 | Avita Piccolo/Exato Infared Ear Thermometer (TS2 & TS4 Series) | Avita Corporation | 2001 | — |
| −11 | K031503 | Avita TS8/TS9 Series IR Ear/Forehead Thermometer | Avita Corporation | 2003 | — |
| −10 | K050463 | Clever TD-1107 Ear/Skin/Surface IR Thermometer, Clever TD-1110… | Taidoc Technology Corporation | 2005 | — |
| −9 | K062445 | Monitoring Ear Thermometer, Model BTM-D1A | Rio Flexon Technology Co., Ltd. | 2007 | — |
| −8 | K081256 | Wireless Body Temperature Monitor, Models BTM-Dic, D, E, F, G and H | Rio Flexon Technology Co., Ltd. | 2008 | — |
| −7 | K100226 | Wireless Body Temperature Monitor Model BTM-Dix Series (BTM-Dic,D,E,F,G & H) | Rio Flexon Technology Co., Ltd. | 2010 | — |
| −6 | K121696 | Wireless Thermometer | Raling Medical Company | 2012 | — |
| −5 | K132761 | Wireless Thermometer | Raiing Medical Company | 2014 | — |
| −4 | K160306 | Cloud Smart Thermometer | Guangzhou Bosma Technology Co, Ltd. | 2016 | — |
| −3 | K181013 | Fever Scout | VivaLNK, Inc. | 2018 | — |
| −2 | K203215 | Radius T wearable thermometer | Masimo Corporation | 2021 | — |
| −1 | K232010 | iTEMPSHIELD | Aion Biosystems, Inc. | 2023 | — |
| 0 (this device) | K250401 | AION TempShield™ | Aion Biosystems, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232010 | iTEMPSHIELDSummary page 5…Code and Regulation Primary iTempShield AION Biosystems K232010 FLL, 21 CFDR 880.2910 Reference / Fever Scout VivaLNK K181013 FLL, 21 CFDR 880.2910… | 2023 |
| * | K181013 | Fever ScoutSummary page 5…ion Primary iTempShield AION Biosystems K232010 FLL, 21 CFDR 880.2910 Reference / Fever Scout VivaLNK K181013 FLL, 21 CFDR 880.2910 Secondary 4. DEVICE DESCRIPTION The AION TempShieldTM is a wearable device that senses body te… | 2018 |
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 24 years and passes through 9 companies; a new generation was cleared every 1.8 years on median.
- None of the 18 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. 2025, 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 MON TempShieldTM is a battery powered wearable thermometer intended for continuous measurement of human body temperature on the upper chest via wireless communication to a smart device application. MON TempShieldTM is intended for single-use and for persons aged 1 year and older in either healthcare facilities or home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250401: AION TempShield™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250401
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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