# K052386: Medtronic M2 Magnet Adjustment Tool

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Neurosurgery
- Decided: Dec 16, 2005 after 107 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: 6 generations back to K944222 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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) Summary page 1.
- K033850: Medtronic PS Medical Strata NSC Valve and Shunt Assemblies with and Without Bioglide, Medtronic Neurosurgery (2004) Summary page 1.
- K042465: PS Medical Strata II Valve, Medtronic Neurosurgery (2004) Summary page 1.

## Indications for use
The Medtronic M2 Adjustment Tool is a magnetic tool that is used to non-invasively adjust the Strata-type Valve when a stronger magnet is warranted by the surgeon. The Medtronic M2 Adjustment Tool is used in conjunction with Strata® handtools.

Source page: https://510kreport.com/device/K052386
Methodology: https://510kreport.com/methodology