# K213089: Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector

- Pathway: 510(k) (Special)
- Applicant: Ivenix, Inc.
- Decided: Nov 10, 2021 after 47 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K011442 (2001). 37 ancestors in all.
No later device cites it as a predicate yet.
15 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183311: Ivenix Infusion System (IIS), Ivenix, Inc. (2019) Summary page 4.

## Indications for use
The Ivenix LVP Epidural Administration Set with NRFit Connector (SET-0030-1) is intended for the controlled administration of pharmaceutical drugs or other patient therapies via the epidural pathway. The Ivenix LVP Epidural Administration Set is intended only for use with the Ivenix Infusion System in a hospital or outpatient care environment.

Source page: https://510kreport.com/device/K213089
Methodology: https://510kreport.com/methodology