Cleared Traditional

K853864 - INTRACRANIAL PRESSURE MONITORING KIT 070

K853864 is the FDA 510(k) clearance for INTRACRANIAL PRESSURE MONITORING KIT 070 by Camino Laboratories, Inc.. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K853864 · Camino Laboratories, Inc. · Neurology device
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Feb 1986
Decision
156d
Days
Class 2
Risk

K853864 is an FDA 510(k) clearance for the INTRACRANIAL PRESSURE MONITORING KIT 070. 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 February 20, 1986 after a review of 156 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.

View all Camino Laboratories, Inc. devices

Submission Details

510(k) Number K853864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1985
Decision Date February 20, 1986
Days to Decision 156 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 148d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K853864.
MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER
K914479 · Codman & Shurtleff, Inc. · Mar 1994
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K884823 · Abbott Laboratories · Jul 1990
CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT
K853770 · Codman & Shurtleff, Inc. · Oct 1986
INTRACRANIAL PRESSURE MONITORING CUP CATHETERS
K854657 · Cordis Corp. · Dec 1985
DISPOSABLE ICP KIT DIFF. SIZES
K840003 · Codman & Shurtleff, Inc. · Feb 1984
INTRACRANIAL PRESSURE MONITORING DEVICE
K822864 · Medex, Inc. · Nov 1982