# K013488: Sophy Pressure Adjustable Valve System Model SM8

- Pathway: 510(k) (Traditional)
- Applicant: Sophysa SA
- Decided: Mar 27, 2002 after 159 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: 3 generations back to K944222 (1995). 4 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992465: Sophy SU8 Pressure Adjustable Valve, Sophysa SA (2000) Summary page 1.

## Most influential descendants
- K031097: Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVB (2004), 8 descendants of its own
- K042481: Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400 (2004), 7 descendants of its own
- K062009: Aesculap-Meithke Progav Programmable Valve, Models FV410T-FV451T (2007), 6 descendants of its own
- K103003: Aesculap- Meithke Progav Programmable Shunt System (2010), 4 descendants of its own
- K141687: Aesculap - Meithke Progav 2.0 Adjustable Shunt System (2015), 2 descendants of its own

## Indications for use
To drain cerebrospinal fluid (CSF) for the management of hydrocephalus

Source page: https://510kreport.com/device/K013488
Methodology: https://510kreport.com/methodology