Cleared Traditional

K172035 - EKOS ultrasound EVD Device

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

K172035 · Btg International, Inc. · Neurology device
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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

Submission Details

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.

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
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