# K971233: Soft Tip Epidural Catheter Kit

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Oct 17, 1997 after 198 days
- Product code: CAZ (Anesthesia Conduction Kit)
- Device class: 2
- Regulation: 21 CFR 868.5140
- 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 K801912 (1980). 2 ancestors in all.
12 later devices descend from it; 2 cite it directly.
1 of 15 devices in its family (counting itself) has 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.
- K801912: Arrow Positive Placement Con/Epidural an, Arrow Intl., Inc. (1980) Summary page 1.

## Most influential descendants
- K030830: B. Braun Nerve Block Catheter (2003), 10 descendants of its own
- K042488: Perifix Catheter and Contiplex Catheter (2004), 9 descendants of its own
- K043500: Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer Needle (2005), 3 descendants of its own
- K061210: Functional  Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B (2006), 2 descendants of its own
- K063071: Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B (2007), 1 descendant of its own

## Indications for use
For the administration of anesthetic agents into the epidural space. B. Braun recommends that the epidural catheter be removed or replaced every 72 hours.

Source page: https://510kreport.com/device/K971233
Methodology: https://510kreport.com/methodology