Cleared Traditional

K192266 - M. Blue Adjustable Shunt System

K192266 is the FDA 510(k) clearance for M. Blue Adjustable Shunt System by Aesculap, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K192266 · Aesculap, Inc. · Neurology device
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Nov 2019
Decision
92d
Days
Class 2
Risk

K192266 is an FDA 510(k) clearance for the M. Blue Adjustable Shunt System. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on November 21, 2019 after a review of 92 days - within the typical 510(k) review window.

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.

View all Aesculap, Inc. devices

Submission Details

510(k) Number K192266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2019
Decision Date November 21, 2019
Days to Decision 92 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
56d faster than avg
Panel avg: 148d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 156
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K192266.
StrataMR II Valves and Shunts
K212641 · Medtronic Neurosurgery · Sep 2021
Ventricular Catheter
K200950 · Aesculap, Inc. · May 2020
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K200807 · Irras USA, Inc. · Apr 2020
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K192289 · Irras USA, Ltd. · Nov 2019
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
K191684 · Integra LifeSciences Corporation · Oct 2019
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
K190174 · Aesculap, Inc. · Jul 2019