Cleared Traditional

K874508 - H-H EXTERNAL VENTRICULAR DRAINAGE COLLE...

K874508 is an FDA 510(k) clearance for H-H EXTERNAL VENTRICULAR DRAINAGE COLLE..., 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 78-day FDA review.

K874508 · Holter-Hausner Intl. · Neurology device
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Jan 1988
Decision
78d
Days
Class 2
Risk

K874508 is an FDA 510(k) clearance for the H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG. 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 January 19, 1988 after a review of 78 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 - K874508

510(k) Number K874508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date January 19, 1988
Days to Decision 78 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
70d faster than avg
Panel avg: 148d · This submission: 78d
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 K874508.
THE PUDENZ IN LINE VALVE
K894072 · Baxter Healthcare Corp · Aug 1989
HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM
K891456 · Baxter Healthcare Corp · Jun 1989
H-H FLUSHING RESERVOIR
K875287 · Holter-Hausner Intl. · Jul 1988
CSF-FLOW CONTROL VALVE, ULTRA SMALL
K873247 · Pudenz-Schulte Medical Research Corp. · Sep 1987
HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS
K871685 · American V. Mueller · Jun 1987
CSF-CARDIAC/PERITONEAL CATHETER
K871752 · Pudenz-Schulte Medical Research Corp. · May 1987