# K041992: Medtronic Stratavarius

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Jan 28, 2005 after 189 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: 4 generations back to K944222 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012052: Medtronic PS Medical Strata Valve, Models 42855, 42865, 92865, 92855, Medtronic PS Medical (2002)
- K040943: Medtronic PS Medical Strata Valve, Medtronic Neurosurgery (2004) Summary page 1.

## Indications for use
StrataVarius is intended for use by physicians, to non-invasively identify the Strata-type valve Performance Level (PL) setting and display that information numerically in terms of PL level and the equivalent pressure reading in millimeters of water (mm H20). The StrataVarius allows the user to change the pressure setting of the valve non-invasively without the need for radiographic confirmation.

Source page: https://510kreport.com/device/K041992
Methodology: https://510kreport.com/methodology