# K232010: iTEMPSHIELD

- Pathway: 510(k) (Traditional)
- Applicant: Aion Biosystems, Inc.
- Decided: Aug 4, 2023 after 29 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: 11 generations back to K010462 (2001). 17 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203215: Radius T wearable thermometer, Masimo Corporation (2021) Summary page 4.

## Most influential descendants
- K250401: AION TempShield™ (2025), 0 descendants of its own

## Indications for use
The iTempShield 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. iTempShield is intended for single use and for persons older than 5 years in healthcare facilities and home environments.

Source page: https://510kreport.com/device/K232010
Methodology: https://510kreport.com/methodology