# K971511: Radionics Contour Flex Valve, Radionics Contour Flex Plus Valve

- Pathway: 510(k) (Traditional)
- Applicant: Radionics, Inc.
- Decided: Jul 24, 1997 after 87 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Radionics Contour Flex Valve and Contour Flex Plus Valve: named in the summary without a submission number

## Most influential descendants
- K042558: Equi-Flow Valve and Shunt System (2004), 0 descendants of its own

## Indications for use
The Contour Flex and Contour Flex Plus Valves are indicated for the treatment of hydrocephalus. They are devices designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. The Contour Flex Plus Valve is indicated for patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the distal catheter of the shunt system.

Source page: https://510kreport.com/device/K971511
Methodology: https://510kreport.com/methodology