Cleared Traditional

K141869 - QFLOW 500 TITANIUM BOLT, QUAD LUMEN BOLT KIT

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

K141869 · Hemedex Incorporated · Neurology device
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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

FDA 510(k) Submission Details - K141869

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
Combination Product No
PCCP Authorized No
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.

GWM Device Classification - Class 2, Special Controls

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 66
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