# K081491: Smith & Nephew CDS System

- Pathway: 510(k) (Special)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 19, 2008 after 22 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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 K960082 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051136: Smith & Nephew CDS System, Smith & Nephew, Inc. (2005) Summary page 1.

## Indications for use
The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.

Source page: https://510kreport.com/device/K081491
Methodology: https://510kreport.com/methodology