Cleared Special

K031086 - CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1

K031086 is an FDA 510(k) clearance for CAMINO SINGLE PARAMETER MONITOR, 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 37-day FDA review.

K031086 · Integra Neurosciences · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
37d
Days
Class 2
Risk

K031086 is an FDA 510(k) clearance for the CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Integra Neurosciences (San Diego, US). The FDA issued a Cleared decision on May 14, 2003 after a review of 37 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 - K031086

510(k) Number K031086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2003
Decision Date May 14, 2003
Days to Decision 37 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
112d faster than avg
Panel avg: 149d · This submission: 37d
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 K031086.
CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
K042728 · Novus Monitoring, Ltd. · Oct 2004
LICOX PMO BRAIN MONITORING SYSTEM
K040235 · Integra LifeSciences Corporation · Apr 2004
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
K032337 · Hemedex Incorporated · Oct 2003
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
K022638 · Neurorecovery, Inc. · Oct 2002
CMA CEREBRAL TISSUE MONITORING SYSTEM
K020285 · Cma Microdialysis AB · Oct 2002
ACT III VENTRICULAR CATHETER
K013705 · Innerspace, Inc. · Sep 2002
K031086 · CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
Download PDF FDA Summary Integra Neurosciences