Cleared Traditional

K853366 - H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT

K853366 is an FDA 510(k) clearance for H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT, manufactured by Holter-Hausner Intl.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K853366 · Holter-Hausner Intl. · Neurology device
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Sep 1985
Decision
30d
Days
Class 2
Risk

K853366 is an FDA 510(k) clearance for the H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Holter-Hausner Intl. (Bridgeport, US). The FDA issued a Cleared decision on September 11, 1985 after a review of 30 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 Holter-Hausner Intl. devices

FDA 510(k) Submission Details - K853366

510(k) Number K853366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date September 11, 1985
Days to Decision 30 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
118d faster than avg
Panel avg: 148d · This submission: 30d
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 K853366.
EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE
K854474 · Cordis Corp. · Nov 1985
H-H ATRIAL CATHETERS & PERITONEAL CATHETERS
K853371 · Holter-Hausner Intl. · Sep 1985
ACCU-FLO PRESSURE VALVE
K853215 · Codman & Shurtleff, Inc. · Sep 1985
H-H FIXATION & JOINING CONNECTORS
K853369 · Holter-Hausner Intl. · Sep 1985
H-H RICKHAM TYPE RESERVOIR
K853364 · Holter-Hausner Intl. · Sep 1985
H-H FIFTH VENTRICLE
K853365 · Holter-Hausner Intl. · Sep 1985