# K050474: Veinnovations Infiltration System

- Pathway: 510(k) (Traditional)
- Applicant: Veinnovations, LLC
- Decided: Apr 14, 2005 after 49 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031432 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031432: Klein Surgical Infiltration Pump, Model Kip-II, Hk Surgical, Inc. (2003) Summary page 4.

## Indications for use
The Veinnovations Infiltration System is an infiltration pump system that is used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional.

Source page: https://510kreport.com/device/K050474
Methodology: https://510kreport.com/methodology