# K231242: Perifix FX Catheter; Contiplex FX Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Sep 15, 2023 after 137 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K840287 (1984). 16 ancestors in all.
No later device cites it as a predicate yet.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991879: Spring-Wound Epidural Catheter, Micor, Inc. (1999) Summary page 4.
- K113059: Contiplex FX, B.Braun Medical, Inc. (2012) Summary page 4.

## Indications for use
The PERIFIX FX Springwound Epidural Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. The catheter should be removed or replaced every 72 hours. The Contiplex FX catheter is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for peripheral plexus anesthesia and pain management. The Contiplex FX catheter may remain indwelling for up to 72 hours.

Source page: https://510kreport.com/device/K231242
Methodology: https://510kreport.com/methodology