# K012052: Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic PS Medical
- Decided: Feb 11, 2002 after 224 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). 8 ancestors in all.
25 later devices descend from it; 6 cite it directly.
1 of 34 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.
- K980778: Hakim Micro Programmable Valve System, Johnson & Johnson Professionals, Inc. (1998) Summary page 1.
- K992465: Sophy SU8 Pressure Adjustable Valve, Sophysa SA (2000) Summary page 1.
- K902783: PS Medical Delta CSF-Flow Control Valve, Pudenz-Schulte Medical Research Corp. (1990) Summary page 1.
- K951258: PS Medical Bioglide CSF-Flow Control Shunt Kit, Pudenz-Schulte Medical Research Corp. (1995) Summary page 1.

## Most influential descendants
- 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
- K060681: Medtronic PS Medical Strata Type Value (2006), 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

## Indications for use
The STRATA™ Valve is a shunt component designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool.

Source page: https://510kreport.com/device/K012052
Methodology: https://510kreport.com/methodology