# K043500: Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer Needle

- Pathway: 510(k) (Traditional)
- Applicant: Innospine, Inc.
- Decided: Apr 15, 2005 after 116 days
- Product code: BSP (Needle, Conduction, Anesthetic (W/Wo Introducer))
- Device class: 2
- Regulation: 21 CFR 868.5150
- 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: 6 generations back to K896422 (1990). 29 ancestors in all.
3 later devices descend from it; 3 cite it directly.
3 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960082: Discography Kit, Spinal Specialties, Inc. (1996) Summary page 2.
- K023140: Versa-Kath Epidural Catheter, Model 156-2124, Epimed International, Inc. (2003) Summary page 2.
- K042488: Perifix Catheter and Contiplex Catheter, B.Braun Medical, Inc. (2004) Summary page 2.
- K013610: Perifix Safety Epidural Needles, B.Braun Medical, Inc. (2002) Summary page 2.
- K022029: Quincke Spinal Needle, Epimed International, Inc. (2002) Summary page 2.
- K040965: Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles, Pajunk GmbH (2004) Summary page 2.

## Most influential descendants
- 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

## Recalls of this device
- Apr 25, 2006 · Not classified · Z-0948-2008: Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.

## Indications for use
The Functional Anaesthetic Discography (FAD) Catheter System is intended for use in delivering either a single dose or continuous administration of a radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space. The FAD Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating placement of the FAD Catheter and Guidewire into the intradiscal space.

Source page: https://510kreport.com/device/K043500
Methodology: https://510kreport.com/methodology