Cleared Traditional

K914735 - VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM

K914735 is an FDA 510(k) clearance for VENTRICULAR PRESSURE MONITORING KIT, manufactured by Camino Laboratories, Inc.. The device is a Class 2 Neurology device with product code GWM cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K914735 · Camino Laboratories, Inc. · Neurology device
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Jan 1992
Decision
88d
Days
Class 2
Risk

K914735 is an FDA 510(k) clearance for the VENTRICULAR PRESSURE MONITORING KIT, MODEL 110-4HM. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Camino Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on January 17, 1992 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Camino Laboratories, Inc. devices

FDA 510(k) Submission Details - K914735

510(k) Number K914735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1991
Decision Date January 17, 1992
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
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 68
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K914735.
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479 · Codman & Shurtleff, Inc. · Mar 1994
CAMINO VENTRICULAR TRANSDUCER ACCESSORY
K930221 · Camino Laboratories, Inc. · Apr 1993
MODEL 704
K912139 · Ivy Biomedical Systems, Inc. · Mar 1992
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories · Jul 1990
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
K883115 · Pmt Corp. · Aug 1988
VENTRICULAR BOLT PRESSURE MONITORING KIT #110-4H
K881183 · Camino Laboratories, Inc. · May 1988