Cleared Special

K050720 - NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100

K050720 is an FDA 510(k) clearance for NEUROSENSOR CEREBRAL BLOOD FLOW AND INT..., manufactured by Integra Neurosciences. The device is a Class 2 Neurology device with product code GWM cleared through the Special 510(k) pathway after a 51-day FDA review.

K050720 · Integra Neurosciences · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
51d
Days
Class 2
Risk

K050720 is an FDA 510(k) clearance for the NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYST.... Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra Neurosciences (Planisboro, US). The FDA issued a Cleared decision on May 11, 2005 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1620 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050720

510(k) Number K050720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2005
Decision Date May 11, 2005
Days to Decision 51 days
Submission Type Special
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
98d faster than avg
Panel avg: 149d · This submission: 51d
Pathway characteristics
Modification to existing cleared device.

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 94
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K050720.
CMA CEREBRAL TISSUE MONITORING SYSTEM
K060554 · Cma Microdialysis AB · May 2006
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT
K051599 · Neurorecovery, Inc. · Jul 2005
NEUROSYSTEMS 1TM MONITOR
K050702 · Neurosystems, LLC · May 2005
MPS (OR MPS-T)
K041838 · Innerspace, Inc. · Mar 2005
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
K042728 · Novus Monitoring, Ltd. · Oct 2004
LICOX PMO BRAIN MONITORING SYSTEM
K040235 · Integra LifeSciences Corporation · Apr 2004
K050720 · NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
Download PDF FDA Summary Integra Neurosciences