Cleared Traditional

K161605 - Smart External Drain (SED) System

K161605 is the FDA 510(k) clearance for Smart External Drain (SED) System by Aqueduct Critical Care, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K161605 · Aqueduct Critical Care, Inc. · Neurology device
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Oct 2016
Decision
139d
Days
Class 2
Risk

K161605 is an FDA 510(k) clearance for the Smart External Drain (SED) System. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Aqueduct Critical Care, Inc. (Bothell, US). The FDA issued a Cleared decision on October 27, 2016 after a review of 139 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 Aqueduct Critical Care, Inc. devices

Submission Details

510(k) Number K161605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2016
Decision Date October 27, 2016
Days to Decision 139 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 148d · This submission: 139d
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 118
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K161605.
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022 · Codman & Shurtleff, Inc. · Oct 2017
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
K161853 · Aesculap, Inc. · Feb 2017
Codman EDS3 CSF External Drainage System
K162437 · Codman & Shurtleff, Inc. · Oct 2016
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
K161992 · Integra LifeSciences Corporation · Sep 2016
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
K153041 · Integra LifeSciences Corporation · Mar 2016
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
K152897 · Integra LifeSciences Corporation · Mar 2016