Cleared Traditional

K042728 - CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM

K042728 is an FDA 510(k) clearance for CAMINO SLIM-LINE INTRACRANIAL MONITORIN..., manufactured by Novus Monitoring, Ltd.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K042728 · Novus Monitoring, Ltd. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
21d
Days
Class 2
Risk

K042728 is an FDA 510(k) clearance for the CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Novus Monitoring, Ltd. (Planisboro, US). The FDA issued a Cleared decision on October 22, 2004 after a review of 21 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.

FDA 510(k) Submission Details - K042728

510(k) Number K042728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2004
Decision Date October 22, 2004
Days to Decision 21 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
128d faster than avg
Panel avg: 149d · This submission: 21d
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 103
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K042728.
NEUROSYSTEMS 1TM MONITOR
K050702 · Neurosystems, LLC · May 2005
NEUROSENSOR CEREBRAL BLOOD FLOW AND INTRACRANIAL PRESSURE MONITORING KIT/SYSTEM, MODELS NS-P, NS-100
K050720 · Integra Neurosciences · May 2005
MPS (OR MPS-T)
K041838 · Innerspace, Inc. · Mar 2005
LICOX PMO BRAIN MONITORING SYSTEM
K040235 · Integra LifeSciences Corporation · Apr 2004
HEMEDEX CRANIAL BOLT MODELS, 3601, 3602
K032337 · Hemedex Incorporated · Oct 2003
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
K031086 · Integra Neurosciences · May 2003
K042728 · CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM
Download PDF FDA Summary Novus Monitoring, Ltd.