Cleared Traditional

K912139 - MODEL 704

K912139 is an FDA 510(k) clearance for MODEL 704, manufactured by Ivy Biomedical Systems, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 316-day FDA review.

K912139 · Ivy Biomedical Systems, Inc. · Neurology device
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Mar 1992
Decision
316d
Days
Class 2
Risk

K912139 is an FDA 510(k) clearance for the MODEL 704. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on March 25, 1992 after a review of 316 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.

View all Ivy Biomedical Systems, Inc. devices

FDA 510(k) Submission Details - K912139

510(k) Number K912139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1991
Decision Date March 25, 1992
Days to Decision 316 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 148d · This submission: 316d
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 66
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K912139.
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · Cordis Corp. · Mar 1995
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479 · Codman & Shurtleff, Inc. · Mar 1994
CAMINO VENTRICULAR TRANSDUCER ACCESSORY
K930221 · Camino Laboratories, Inc. · Apr 1993
VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM
K914735 · Camino Laboratories, Inc. · Jan 1992
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories · Jul 1990
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
K883115 · Pmt Corp. · Aug 1988