# K250401: AION TempShield™

- Pathway: 510(k) (Traditional)
- Applicant: Aion Biosystems, Inc.
- Decided: Mar 14, 2025 after 30 days
- Product code: FLL (Continuous Measurement Thermometer)
- Device class: 2
- Regulation: 21 CFR 880.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K010462 (2001). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232010: iTEMPSHIELD, Aion Biosystems, Inc. (2023) Summary page 5.
- K181013: Fever Scout, VivaLNK, Inc. (2018) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K250401
Methodology: https://510kreport.com/methodology