Cleared Traditional

K013705 - ACT III VENTRICULAR CATHETER

K013705 is an FDA 510(k) clearance for ACT III VENTRICULAR CATHETER, 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 305-day FDA review.

K013705 · Innerspace, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
305d
Days
Class 2
Risk

K013705 is an FDA 510(k) clearance for the ACT III 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 September 9, 2002 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K013705

510(k) Number K013705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2001
Decision Date September 09, 2002
Days to Decision 305 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
156d slower than avg
Panel avg: 149d · This submission: 305d
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 K013705.
CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1
K031086 · Integra Neurosciences · May 2003
NEURORECOVERY VENTRICULAR CATHETER & MAIN VALVE ASSEMBLY KIT
K022638 · Neurorecovery, Inc. · Oct 2002
CMA CEREBRAL TISSUE MONITORING SYSTEM
K020285 · Cma Microdialysis AB · Oct 2002
CAMINO INTRACRANIAL PRESSURE MONITORING CATHETER WITH LICOX IMC BOLT FITTING, MODEL 110-4L
K022553 · Integra Neurosciences · Aug 2002
TRANSTAR INTRACRANIAL PRESSURE TRANSDUCER, MODEL MX950ICP
K020780 · Medex, Inc. · May 2002
LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE
K020558 · Integra Neurosciences · Mar 2002
K013705 · ACT III VENTRICULAR CATHETER
Download PDF FDA Summary Innerspace, Inc.