Cleared Traditional

K161010 - HICP200 Patient/Monitor Interconnect Cable

K161010 is an FDA 510(k) clearance for HICP200 Patient/Monitor Interconnect Cable, manufactured by Innerspace Neuro Solutions, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K161010 · Innerspace Neuro Solutions, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
192d
Days
Class 2
Risk

K161010 is an FDA 510(k) clearance for the HICP200 Patient/Monitor Interconnect Cable. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Innerspace Neuro Solutions, Inc. (Tustin, US). The FDA issued a Cleared decision on October 20, 2016 after a review of 192 days - an extended review 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: 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 - K161010

510(k) Number K161010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2016
Decision Date October 20, 2016
Days to Decision 192 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
43d slower than avg
Panel avg: 149d · This submission: 192d
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 K161010.
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K161010 · HICP200 Patient/Monitor Interconnect Cable
Download PDF FDA Summary Innerspace Neuro Solu…