# K141227: Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with Siphonx

- Pathway: 510(k) (Traditional)
- Applicant: Sophysa SA
- Decided: Apr 2, 2015 after 325 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K250636: Sophy Mini Monopressure Valve (SM1) (2025), 0 descendants of its own
- K222422: Polaris Valve Electronic Reading Instrument (2023), 0 descendants of its own

## Indications for use
The Polaris® Adjustable Pressure Valve is designed for the treatment of hydrocephalus by shunting the Cerebrospinal Fluid (CSF) to the abdominal cavity or right atrium of the heart.

Source page: https://510kreport.com/device/K141227
Methodology: https://510kreport.com/methodology