# K061210: Functional  Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B

- Pathway: 510(k) (Special)
- Applicant: Kyphon, Inc.
- Decided: Jun 27, 2006 after 57 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: 7 generations back to K896422 (1990). 30 ancestors in all.
2 later devices descend from it; 2 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)
- K043500: Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer Needle, Innospine, Inc. (2005) Summary page 1.

## Most influential descendants
- 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

## 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 Functional Anaesthetic Discography (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/K061210
Methodology: https://510kreport.com/methodology