Cleared Traditional

K870660 - H-H EXTERNAL VENTRICULAR DRAIN (EVD) CO...

K870660 is an FDA 510(k) clearance for H-H EXTERNAL VENTRICULAR DRAIN (EVD) CO..., 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 71-day FDA review.

K870660 · Holter-Hausner Intl. · Neurology device
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May 1987
Decision
71d
Days
Class 2
Risk

K870660 is an FDA 510(k) clearance for the H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS. 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 May 1, 1987 after a review of 71 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 - K870660

510(k) Number K870660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1987
Decision Date May 01, 1987
Days to Decision 71 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
77d faster than avg
Panel avg: 148d · This submission: 71d
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 K870660.
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
HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM
K864676 · American V. Mueller · Dec 1986
P-S MEDICAL CSF-SIPHON CONTROL DEVICE
K862907 · Pudenz-Schulte Medical Research Corp. · Dec 1986
BECKER EXTERNAL DRAINAGE/MONITOR SYS LUMBAR CATH.
K862303 · Pudenz-Schulte Medical Research Corp. · Aug 1986