# Ivenix, Inc.

- Location (FDA's records): North Andover, MA
- FDA decisions: 2 (2019–2021): 2 510(k) clearances
- Product codes: FPA (1), FRN (1)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 25 (13 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Baxter Healthcare Corp: 1 (https://510kreport.com/company/baxter-healthcare)
- Hospira, Inc.: 1 (https://510kreport.com/company/hospira)

## Its most-cited devices
- K183311: Ivenix Infusion System (IIS) (2019), cited by 1

## Recent decisions
- K213089: Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector (Nov 10, 2021)
- K183311: Ivenix Infusion System (IIS) (Jun 7, 2019)

Source page: https://510kreport.com/company/ivenix