# K152700: StrataMR Valves and Shunts

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Apr 7, 2016 after 199 days
- Product code: JXG (Shunt, Central Nervous System And Components)
- Device class: 2
- Regulation: 21 CFR 882.5550
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K944222 (1995). 13 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060681: Medtronic PS Medical Strata Type Value, Medtronic Neurosurgery (2006) Summary page 4.

## Most influential descendants
- K212641: StrataMR II Valves and Shunts (2021), 0 descendants of its own
- K181622: StrataMR guider tool (2018), 0 descendants of its own

## Recalls of this device
- Feb 22, 2017 · Class I · Z-1702-2017: Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in the incorrect orientation, higher valve opening pres

## Indications for use
The Medtronic StrataMR™ 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 for radiographic confirmation.

Source page: https://510kreport.com/device/K152700
Methodology: https://510kreport.com/methodology