Cleared Traditional

K982702 - VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD

K982702 is an FDA 510(k) clearance for VENTRIX SUBDURAL TUNNELING PRESSURE MON..., 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 38-day FDA review.

K982702 · Camino Neurocare, Inc. · Neurology device
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Sep 1998
Decision
38d
Days
Class 2
Risk

K982702 is an FDA 510(k) clearance for the VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD. 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 September 10, 1998 after a review of 38 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Camino Neurocare, Inc. devices

FDA 510(k) Submission Details - K982702

510(k) Number K982702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1998
Decision Date September 10, 1998
Days to Decision 38 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 148d · This submission: 38d
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 K982702.
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