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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 149d · 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 90
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K010422.
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
K020558 · Integra Neurosciences · Mar 2002
NEUROSENSOR
K013930 · Novus Monitoring, Ltd. · Feb 2002
AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR
K003759 · Aesculap, Inc. · Jun 2001
ACTI-ICP MONITORING SYSTEM
K003905 · Innerspace, Inc. · Jun 2001
LICOX CMP MONITOR-AC3.1, LICOX IMC OXYGEN CATHETERS-CC1,CC1.SB LUICOX IMC INTRODUCER KITS-IM,IM2,IM3,II1 LICOXIMC TEMPE
K002765 · Integra Neurosciences · Nov 2000
VENTRIX TRUE TECH VENTRICULAR TUNNELING PRESSURE MONITORING KIT, MODEL NL960-V
K002392 · Integra Neurocare, LLC · Nov 2000
K010422 · ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER
Download PDF FDA Summary Innerspace, Inc.