Cleared Special

K181301 - Smart External Drain (SED) System

K181301 is an FDA 510(k) clearance for Smart External Drain (SED) System, manufactured by Aqueduct Critical Care, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Special 510(k) pathway after a 28-day FDA review.

K181301 · Aqueduct Critical Care, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
28d
Days
Class 2
Risk

K181301 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 June 14, 2018 after a review of 28 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.

FDA 510(k) Submission Details - K181301

510(k) Number K181301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2018
Decision Date June 14, 2018
Days to Decision 28 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: 149d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 250
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K181301.
Codman Certas Plus Electronic Tool Kit
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StrataMR guider tool
K181622 · Medtronic Neurosurgery · Oct 2018
IRRAflow CNS System
K171880 · Irras, Inc. · Jul 2018
EKOS ultrasound EVD Device, EVD Control Unit
K172035 · Btg International, Inc. · Mar 2018
Smart External Drain (SED) System
K172759 · Aqueduct Critical Care, Inc. · Nov 2017
Alivio Ventricular Catheter and Flusher System (Alivio System)
K172006 · Alcyone Lifesciences, Inc. · Nov 2017
K181301 · Smart External Drain (SED) System
Download PDF FDA Summary Aqueduct Critical Car…