Cleared Traditional

K172035 - EKOS ultrasound EVD Device, EVD Control Unit

K172035 is an FDA 510(k) clearance for EKOS ultrasound EVD Device, manufactured by Btg International, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K172035 · Btg International, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
262d
Days
Class 2
Risk

K172035 is an FDA 510(k) clearance for the EKOS ultrasound EVD Device, EVD Control Unit. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Btg International, Inc. (Bothell, US). The FDA issued a Cleared decision on March 24, 2018 after a review of 262 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.

View all Btg International, Inc. devices

FDA 510(k) Submission Details - K172035

510(k) Number K172035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2017
Decision Date March 24, 2018
Days to Decision 262 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 148d · This submission: 262d
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 220
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K172035.
StrataMR guider tool
K181622 · Medtronic Neurosurgery · Oct 2018
IRRAflow CNS System
K171880 · Irras, Inc. · Jul 2018
Smart External Drain (SED) System
K181301 · Aqueduct Critical Care, Inc. · Jun 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
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
K172537 · Codman & Shurtleff, Inc. · Oct 2017