Cleared Traditional

K113088 - HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)

K113088 is an FDA 510(k) clearance for HUMMINGBIRD SUBDURAL H900DS (DRAINAGE A..., 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 196-day FDA review.

K113088 · Innerspace, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
196d
Days
Class 2
Risk

K113088 is an FDA 510(k) clearance for the HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (.... Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Innerspace, Inc. (Tustin, US). The FDA issued a Cleared decision on May 2, 2012 after a review of 196 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 - K113088

510(k) Number K113088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2011
Decision Date May 02, 2012
Days to Decision 196 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
47d slower than avg
Panel avg: 149d · This submission: 196d
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 K113088.
INTEGRA LICOX PTO2 MONITOR
K131184 · Integra Lifesciences Corp. · Aug 2013
INTEGRA CAMINO ICP MONITOR
K121573 · Intrgra Lifesciences Corporation · Sep 2012
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH INTRGRA CAMINO FLEX ADAPTER
K121159 · Integra Lifescience Corportation · Jul 2012
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
K120252 · Raumedic AG · Apr 2012
RAUMEDIC ICP MONITORING SYSTEM
K112017 · Raumedic AG · Oct 2011
RAUMEDIC- ICP-MONITORING SYSTEM
K103206 · Raumedic AG · Mar 2011
K113088 · HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY)
Download PDF FDA Summary Innerspace, Inc.