Cleared Special

K072379 - MPS OXIPORT AND MPS OXIPORT PLUS

K072379 is an FDA 510(k) clearance for MPS OXIPORT AND MPS OXIPORT PLUS, manufactured by Innerspace, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Special 510(k) pathway after a 249-day FDA review.

K072379 · Innerspace, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
249d
Days
Class 2
Risk

K072379 is an FDA 510(k) clearance for the MPS OXIPORT AND MPS OXIPORT PLUS. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Innerspace, Inc. (Tustin, US). The FDA issued a Cleared decision on April 29, 2008 after a review of 249 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. 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. Standard predicate reliance. 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 - K072379

510(k) Number K072379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2007
Decision Date April 29, 2008
Days to Decision 249 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
100d slower than avg
Panel avg: 149d · This submission: 249d
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 90
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K072379.
SENSOMETRICS SOFTWARE
K101133 · Dpcom AS · Nov 2010
SYNERGY
K083378 · Innerspace, Inc. · Sep 2009
MODIFICATION TO CMA CEREBRAL TISSUE MONITORING SYSTEM
K071984 · Cma Microdialysis AB · Jun 2008
MODIFICATION TO NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING SYSTEM
K071505 · Integra LifeSciences Corporation · Aug 2007
PRESSIO ICP MONITORING SYSTEM
K062584 · Sophysa SA · Jul 2007
INTEGRA MOBIUS MULTI-MODALITY MONITORING SYSTEM
K061640 · Integra LifeSciences Corporation · Jul 2006
K072379 · MPS OXIPORT AND MPS OXIPORT PLUS
Download PDF FDA Summary Innerspace, Inc.