# K090884: Perifix One Pediatric Catheter, 20 GA. & 24 GA.

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jun 29, 2009 after 90 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: 6 generations back to K896422 (1990). 25 ancestors in all.
No later device cites it as a predicate yet.
1 of 26 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042488: Perifix Catheter and Contiplex Catheter, B.Braun Medical, Inc. (2004) Summary page 1.
- K033080: Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter, Portex, Inc. (2004) Summary page 1.
- K062902: Pajunks Epilong Set Pediatric, PAJUNK GmbH Medizintechnologie (2007) Summary page 1.

## Indications for use
The B. Braun Perifix ONE® Pediatric Catheter is intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery for pediatric patients within the subgroups of Child (2 to 12 years of, age) and Adolescent (12 to 21 years of age). Routes of Administration include epidural and perineural (peripheral nerve block) with a duration of use no longer than 72 hours.

Source page: https://510kreport.com/device/K090884
Methodology: https://510kreport.com/methodology