Cleared Traditional

K172209 - AURA ICP MONITORING SYSTEM

K172209 is the FDA 510(k) clearance for AURA ICP MONITORING SYSTEM by Branchpoint Technologies, Inc.. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K172209 · Branchpoint Technologies, Inc. · Neurology device
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May 2018
Decision
298d
Days
Class 2
Risk

K172209 is an FDA 510(k) clearance for the AURA ICP MONITORING SYSTEM. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Branchpoint Technologies, Inc. (Irvine, US). The FDA issued a Cleared decision on May 18, 2018 after a review of 298 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - 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 Branchpoint Technologies, Inc. devices

Submission Details

510(k) Number K172209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2017
Decision Date May 18, 2018
Days to Decision 298 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
150d slower than avg
Panel avg: 148d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GWM Device, Monitoring, Intracranial Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1620
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 - GWM Device, Monitoring, Intracranial Pressure

All 29
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K172209.
Becker External Drainage and Monitoring System
K200456 · Medtronic, Inc. · Mar 2020
BcSs-PICNI-2000 Sensor
K182073 · Braincare Desenvolvimento E Inovacao Tecnologica S.A. · Oct 2019
CereLink ICP Monitor, CereLink ICP Extension Cable
K183406 · Integra Lifesciences Corp. · Jan 2019
CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
K173192 · Codman & Shurtleff, Inc. · Nov 2017
Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit
K153347 · Codman & Shurtleff, Inc. · Aug 2016
DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables
K152670 · Medos International SARL · Jan 2016