# K250636: Sophy Mini Monopressure Valve (SM1)

- Pathway: 510(k) (Traditional)
- Applicant: Sophysa
- Decided: Nov 28, 2025 after 270 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 K141227 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141227: Polaris Pressure Adjustable Valve System/Polaris Adjustable Valve with Siphonx, Sophysa SA (2015) Summary page 6.

## Indications for use
The Sophy Mini Monopressure Valve is designed for the treatment of hydrocephalus by shunting cerebrospinal fluid (CSF) to the abdominal cavity or right atrium of the heart.

Source page: https://510kreport.com/device/K250636
Methodology: https://510kreport.com/methodology