Cleared Traditional

K853215 - ACCU-FLO PRESSURE VALVE

K853215 is the FDA 510(k) clearance for ACCU-FLO PRESSURE VALVE by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code JXG) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K853215 · Codman & Shurtleff, Inc. · Neurology device
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Sep 1985
Decision
46d
Days
Class 2
Risk

K853215 is an FDA 510(k) clearance for the ACCU-FLO PRESSURE VALVE. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 46 days - a notably fast clearance cycle.

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: 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K853215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1985
Decision Date September 16, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 148d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 117
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K853215.
STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES
K861377 · Cordis Corp. · Jun 1986
EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID
K855058 · Cordis Corp. · Jan 1986
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
K854474 · Cordis Corp. · Nov 1985
RADIONICS MINI & STANDARD SHUNT VALVE
K843132 · Radionics, Inc. · Sep 1984