Cleared Traditional

K882552 - METATECH ROBINSON BOLT ACCESSORY

K882552 is the FDA 510(k) clearance for METATECH ROBINSON BOLT ACCESSORY by Metatech Corp.. It is a Class 2 Neurology device (product code GWM) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K882552 · Metatech Corp. · Neurology device
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Sep 1988
Decision
79d
Days
Class 2
Risk

K882552 is an FDA 510(k) clearance for the METATECH ROBINSON BOLT ACCESSORY. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Metatech Corp. (Wheeling, US). The FDA issued a Cleared decision on September 8, 1988 after a review of 79 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 Metatech Corp. devices

Submission Details

510(k) Number K882552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1988
Decision Date September 08, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 148d · This submission: 79d
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 K882552.
CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER
K940648 · Cordis Corp. · Mar 1995
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