Cleared Traditional

K962928 - COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/)

K962928 is an FDA 510(k) clearance for COMBINED INTRACRANIAL PRESSURE-TEMPERAT..., manufactured by Camino Neurocare, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K962928 · Camino Neurocare, Inc. · Neurology device
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Dec 1996
Decision
144d
Days
Class 2
Risk

K962928 is an FDA 510(k) clearance for the COMBINED INTRACRANIAL PRESSURE-TEMPERATURE SENSING SYSTEM (ICP/). Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Camino Neurocare, Inc. (San Diego, US). The FDA issued a Cleared decision on December 20, 1996 after a review of 144 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 Camino Neurocare, Inc. devices

FDA 510(k) Submission Details - K962928

510(k) Number K962928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1996
Decision Date December 20, 1996
Days to Decision 144 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
4d faster than avg
Panel avg: 148d · This submission: 144d
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 51
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K962928.
VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
K982702 · Camino Neurocare, Inc. · Sep 1998
PARENCHYMAL BOLT PRESSURE MONITORING KIT
K981846 · Camino Neurocare, Inc. · Aug 1998
CODMAN INTRACRANIAL BOLT
K974088 · Johnson & Johnson Professionals, Inc. · Jan 1998
COMAN(R) CU-11 MODEL NUMBER 82-6634
K945585 · Johnson & Johnson Professionals, Inc. · Oct 1995
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · Cordis Corp. · Mar 1995
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479 · Codman & Shurtleff, Inc. · Mar 1994