Cleared Traditional

K991222 - CODMAN MICROSENSOR VENTRICULAR CATHETER KIT

K991222 is an FDA 510(k) clearance for CODMAN MICROSENSOR VENTRICULAR CATHETER KIT, manufactured by Johnson & Johnson Professionals, 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.

K991222 · Johnson & Johnson Professionals, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
88d
Days
Class 2
Risk

K991222 is an FDA 510(k) clearance for the CODMAN MICROSENSOR VENTRICULAR CATHETER KIT. Classified as Device, Monitoring, Intracranial Pressure (product code GWM), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on July 9, 1999 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 Johnson & Johnson Professionals, Inc. devices

FDA 510(k) Submission Details - K991222

510(k) Number K991222 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1999
Decision Date July 09, 1999
Days to Decision 88 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
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 71
Devices cleared under the same product code (GWM) and FDA review panel - the closest regulatory comparables to K991222.
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NEUROTREND MULTIPARAMETER SENSOR, C7004S, TO OPERATE WITH PARATREND 7+ MULTIPARAMETER SENSOR, MPM7001S, AND SATELLITE MS
K980380 · Diametrics Medical, Ltd. · Jul 1999
MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM, MEDTRONIC PS MEDICAL NIVEAU DRAINAGE SYSTEM POLE CLAMP, MEDTRONIC PS MEDICL
K983799 · Medtronic PS Medical · Jan 1999
VENTRIX SUBDURAL TUNNELING PRESSURE MONITORING KIT MODEL NL950-SD
K982702 · Camino Neurocare, Inc. · Sep 1998
PARENCHYMAL BOLT PRESSURE MONITORING KIT
K981846 · Camino Neurocare, Inc. · Aug 1998