# K212641: StrataMR II Valves and Shunts

- Pathway: 510(k) (Special)
- Applicant: Medtronic Neurosurgery
- Decided: Sep 16, 2021 after 27 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: 8 generations back to K944222 (1995). 14 ancestors in all.
No later device cites it as a predicate yet.
1 of 15 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152700: StrataMR Valves and Shunts, Medtronic Neurosurgery (2016) Summary page 5.

## Indications for use
The StrataMR II Valves and shunts are designed to provide continuous Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasively adjust valve pressure/performance level pre-and post-implantation by using magnetic adjustment tools without the need of radiographic confirmation.

Source page: https://510kreport.com/device/K212641
Methodology: https://510kreport.com/methodology