Cleared Special

StrataMR II Valves and Shunts (K212641) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K212641 · Medtronic Neurosurgery · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
27d
Days
Class 2
Risk

K212641 is an FDA 510(k) clearance for the StrataMR II Valves and Shunts. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Medtronic Neurosurgery (Irvine, US). The FDA issued a Cleared decision on September 16, 2021 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Neurosurgery devices

Submission Details

510(k) Number K212641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2021
Decision Date September 16, 2021
Days to Decision 27 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 148d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXG Shunt, Central Nervous System And Components

All 89
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K212641.
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M. Blue Adjustable Shunt System
K192266 · Aesculap, Inc. · Nov 2019