# K992465: Sophy SU8 Pressure Adjustable Valve

- Pathway: 510(k) (Traditional)
- Applicant: Sophysa SA
- Decided: Sep 21, 2000 after 426 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: 2 generations back to K944222 (1995). 3 ancestors in all.
29 later devices descend from it; 2 cite it directly.
1 of 33 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974739: Hakim Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K861377: Standard/Pediatric Cordis Hydrocephalus Valves, Cordis Corp. (1986) Summary page 1.

## Most influential descendants
- K012052: Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855 (2002), 25 descendants of its own
- K033850: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide (2004), 23 descendants of its own
- K042465: PS Medical Strata II Valve (2004), 19 descendants of its own
- K013488: Sophy Pressure Adjustable Valve System Model SM8 (2002), 9 descendants of its own
- K031097: Polaris Pressure Adjustable Valve System Modes SPV, Spva, SPVB (2004), 8 descendants of its own

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

Source page: https://510kreport.com/device/K992465
Methodology: https://510kreport.com/methodology