# K013610: Perifix Safety Epidural Needles

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jan 25, 2002 after 81 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- 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 K813179 (1981). 2 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813179: Perican, Epidural Cannula, Burron Medical Products, Inc. (1981) Summary page 1.
- K813186: Perfix Set for Epidural Anesthesia W/Tuo, Burron Medical Products, Inc. (1981) Summary page 1.

## Most influential descendants
- 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
- K073516: Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular (2008), 0 descendants of its own
- K032981: Sppro Esp, Models Esp 603-18-05, Esp 603-18-09 (2004), 0 descendants of its own

## Indications for use
An active needle stick prevention device used by physicians to access the epidural space for the purpose of delivering an anesthetic and/or therapeutic agent or to facilitate placement of an epidural catheter. The needle can be used for single dose administration or in conjunction with the epidural catheter for continuous administration.

Source page: https://510kreport.com/device/K013610
Methodology: https://510kreport.com/methodology