# K974708: Gemini Standard and Mini Valves

- Pathway: 510(k) (Traditional)
- Applicant: Neurocare Group
- Decided: Mar 10, 1998 after 83 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
Longest line of descent: 1 generation back to K802586 (1980). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K802586: American Heyer-Schulte Low Profile Valve, American Heyer Schulte (1980) Summary page 1.
- K961859: Novus Standard and Pediatric Valves, Integra Neurocare, LLC (1996) Summary page 1.

## Most influential descendants
- K153041: Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling (2016), 0 descendants of its own

## Indications for use
The Gemini Standard and Mini Valves are utilized in the treatment of hydrocephalic patients. They are components in systems designed to shunt cerebrospinal fiuid (CSF) from the lateral ventricles of the brain into either the right atrium of the heart or the peritoneal cavity. This device should only be used by a physician or qualified personnel under the direction of a physician. Care must be taken to ensure compliance with the manufacturer’s instructions for use.

Source page: https://510kreport.com/device/K974708
Methodology: https://510kreport.com/methodology