# K962696: Perifix Pediatric Epidural Kit

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Apr 3, 1997 after 266 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K813186 (1981). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813186: Perfix Set for Epidural Anesthesia W/Tuo, Burron Medical Products, Inc. (1981) Summary page 1.
- K893766: Lifecare Cont. Epidural Cath. for Morphine Sulfate, Abbott Laboratories (1989) Summary page 1.
- K953467: B-D Spinal Anesthesia Tray Spinal, Bd Becton Dickinson Vacutainer Systems Preanalytic (1995) Summary page 1.

## Most influential descendants
- K033080: Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter (2004), 2 descendants of its own
- K062902: Pajunks Epilong Set Pediatric (2007), 1 descendant of its own
- K090884: Perifix One Pediatric Catheter, 20 GA. & 24 GA. (2009), 0 descendants of its own

## Recalls of this device
- Aug 27, 2015 · Class II · Z-0150-2016: Potential discoloration of the DuraPrep solution from unintended exposure to the sterilant during sterilization performed by the supplier.

## Indications for use
The Perifix Pediatric Epidural Kit is designed to provide pediatric patients, who are undergoing a surgical procedure, with regional anesthesia below the level of the tenth thoracic vertebrae.

Source page: https://510kreport.com/device/K962696
Methodology: https://510kreport.com/methodology