Cleared Traditional

K141869 - QFLOW 500 TITANIUM BOLT

K141869 is the FDA 510(k) clearance for QFLOW 500 TITANIUM BOLT by Hemedex Incorporated. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K141869 · Hemedex Incorporated · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
91d
Days
Class 2
Risk

K141869 is an FDA 510(k) clearance for the QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Hemedex Incorporated (Cambridge, US). The FDA issued a Cleared decision on October 10, 2014 after a review of 91 days - within the typical 510(k) review window.

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 Hemedex Incorporated devices

Submission Details

510(k) Number K141869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2014
Decision Date October 10, 2014
Days to Decision 91 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
57d faster than avg
Panel avg: 148d · This submission: 91d
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 38
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K141869.
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
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER
K133754 · Integra LifeSciences Corporation · Mar 2014
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT
K102875 · Integra LifeSciences Corporation · Dec 2010
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
K071505 · Integra LifeSciences Corporation · Aug 2007