Cleared Traditional

K981246 - BEVERLY REFERENTIAL VALVE (NL850-9710) ...

K981246 is an FDA 510(k) clearance for BEVERLY REFERENTIAL VALVE (NL850-9710) ..., manufactured by Integra Neurocare, LLC. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 415-day FDA review.

K981246 · Integra Neurocare, LLC · Neurology device
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May 1999
Decision
415d
Days
Class 2
Risk

K981246 is an FDA 510(k) clearance for the BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL8.... Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Integra Neurocare, LLC (Pleasant Prairie, US). The FDA issued a Cleared decision on May 26, 1999 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5550 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all Integra Neurocare, LLC devices

FDA 510(k) Submission Details - K981246

510(k) Number K981246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1998
Decision Date May 26, 1999
Days to Decision 415 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
267d slower than avg
Panel avg: 148d · This submission: 415d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXG Device Classification - Class 2, Special Controls

Product Code JXG Shunt, Central Nervous System And Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5550
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 - JXG Shunt, Central Nervous System And Components

All 177
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K981246.
SIPHONGUARD CSF CONTROL DEVICE
K992173 · Johnson & Johnson Professionals, Inc. · Apr 2000
RADIONICS LUMBOPERITONEAL SHUNT
K000057 · Radionics, Inc. · Mar 2000
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K992379 · Radionics, Inc. · Sep 1999
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
K980903 · Radionics, Inc. · Apr 1999
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778 · Johnson & Johnson Professionals, Inc. · Jul 1998
HAKIM PROGRAMMABLE VALVE SYSTEM
K974739 · Johnson & Johnson Professionals, Inc. · Jul 1998