# K024190: Fenestrated Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Promedic, Inc.
- Decided: Mar 17, 2003 after 88 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: 3 generations back to K904788 (1990). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994374: Soaker Catheter, I-Flow Corp. (2000) Summary page 1.
- K991619: FOUNTAIN Infusion Catheter and Occluding Guide Wire, Merit Medical Systems, Inc. (1999) Summary page 1.

## Indications for use
For use in a kit for nerve blocks or wound site pain management. To provide continuous or intermittent delivery of local anesthetics or other medications to surgical wound sites and/or close proximity to nerves outside the epidural space. Routes of administration may be intraoperative or percutaneous. As an accessory to Sorenson Medical infusion pumps or as a standalone device, but not for use with gravity feed. Single patient use only.

Source page: https://510kreport.com/device/K024190
Methodology: https://510kreport.com/methodology