# K090342: Polaris Pressure Adjustable Valve, Models SPV, Spva, SPVB, SPV-140, SPV-300, SPV-400

- Pathway: 510(k) (Traditional)
- Applicant: Sophysa SA
- Decided: Aug 11, 2009 after 182 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 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 no predicate by number.

## Most influential descendants
- K112156: Codman Certas Programmable Valve System, Codman Certas Therapy Management System (2011), 3 descendants of its own
- K143111: Codman Certas Plus Programmable Valve; Codman Certas Toll Kit (2015), 1 descendant of its own
- K181902: Codman Certas Plus Electronic Tool Kit (2018), 0 descendants of its own
- K113526: Codman Certas Programmable Valve System (2012), 0 descendants of its own

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

Source page: https://510kreport.com/device/K090342
Methodology: https://510kreport.com/methodology