# Aion Biosystems, Inc.

- Location (FDA's records): Darien, CT
- FDA decisions: 2 (2023–2025): 2 510(k) clearances
- Product codes: FLL (2)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Masimo Corporation: 1 (https://510kreport.com/company/masimo)
- VivaLNK, Inc.: 1 (https://510kreport.com/company/vivalnk)

## Its most-cited devices
- K232010: iTEMPSHIELD (2023), cited by 1

## Recent decisions
- K250401: AION TempShield™ (Mar 14, 2025)
- K232010: iTEMPSHIELD (Aug 4, 2023)

Source page: https://510kreport.com/company/aion-biosystems