# K212328: DiscCath Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Disccath, LLC
- Decided: Sep 26, 2021 after 61 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: 2 generations back to K911260 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173155: Pakter Curved Needle Set, Cook Incorporated (2018) Summary page 4.

## Indications for use
The DiscCath Needle Set is intended to provide access into the intervertebral disc for discography and injection of fluids. The device is intended for adult patients.

Source page: https://510kreport.com/device/K212328
Methodology: https://510kreport.com/methodology