Cleared Traditional

K012052 - MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855

K012052 is an FDA 510(k) clearance for MEDTRONIC PS MEDICAL STRATA VALVE, manufactured by Medtronic PS Medical. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K012052 · Medtronic PS Medical · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
224d
Days
Class 2
Risk

K012052 is an FDA 510(k) clearance for the MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Medtronic PS Medical (Goleta, US). The FDA issued a Cleared decision on February 11, 2002 after a review of 224 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K012052

510(k) Number K012052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2001
Decision Date February 11, 2002
Days to Decision 224 days
Submission Type Traditional
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
75d slower than avg
Panel avg: 149d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

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 259
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K012052.
CODMAN HAKIM SHUNT SYSTEMS
K020667 · Codman & Shurtleff, Inc. · Mar 2002
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
K013488 · Sophysa SA · Mar 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030 · Aesculap, Inc. · Mar 2002
HAKIM PROGRAMMER AND TRANSMITTER
K003564 · Codman & Shurtleff, Inc. · Dec 2000
SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901
K002970 · Medical Designs, LLC · Dec 2000
LUMBOPERITONEAL SHUNT SYSTEM
K002476 · Phoenix Biomedical Corp. · Nov 2000
K012052 · MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855
Download PDF FDA Summary Medtronic PS Medical