Cleared Traditional

K010422 - ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER

K010422 is an FDA 510(k) clearance for ACT II ICP MONITORING SYSTEM AND VENTRI..., manufactured by Innerspace, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K010422 · Innerspace, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
136d
Days
Class 2
Risk

K010422 is an FDA 510(k) clearance for the ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Innerspace, Inc. (Santa Ana, US). The FDA issued a Cleared decision on June 28, 2001 after a review of 136 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 Innerspace, Inc. devices

FDA 510(k) Submission Details - K010422

510(k) Number K010422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2001
Decision Date June 28, 2001
Days to Decision 136 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 148d · This submission: 136d
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 47
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K010422.
LICOX PMO BRAIN MONITORING SYSTEM
K040235 · Integra LifeSciences Corporation · Apr 2004
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · Medex, Inc. · May 2002
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759 · Aesculap, Inc. · Jun 2001
CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS
K992591 · Codman & Shurtleff, Inc. · Oct 1999
CODMAN MICROSENSOR VENTRICULAR CATHETER KIT
K991222 · Johnson & Johnson Professionals, Inc. · Jul 1999
CODMAN INTRACRANIAL BOLT
K974088 · Johnson & Johnson Professionals, Inc. · Jan 1998