Cleared Traditional

K791075 - H-H SLOTTED CATHETER-RESERVOIR

K791075 is an FDA 510(k) clearance for H-H SLOTTED CATHETER-RESERVOIR, 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 52-day FDA review.

K791075 · Holter-Hausner Intl. · Neurology device
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Aug 1979
Decision
52d
Days
Class 2
Risk

K791075 is an FDA 510(k) clearance for the H-H SLOTTED CATHETER-RESERVOIR. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Holter-Hausner Intl. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 52 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 - K791075

510(k) Number K791075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1979
Decision Date August 03, 1979
Days to Decision 52 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
96d faster than avg
Panel avg: 148d · This submission: 52d
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 K791075.
H-H FIFTH VENTRICLE
K800168 · Holter-Hausner Intl. · Jan 1980
CSF-CARDIAC/PERITONEAL CATHETER
K792005 · Pudenz-Schulte Medical Research Corp. · Jan 1980
CSF-VENTRICULAR CATHETER, STANDARD DES
K792007 · Pudenz-Schulte Medical Research Corp. · Jan 1980
H-H SLOTTED VENTRICULAR CATHETER
K791076 · Holter-Hausner Intl. · Aug 1979
H-H FIXATION AND JOINING CONNECTORS
K790849 · Holter-Hausner Intl. · May 1979
VALVE, H-H CRUCIFORM SLIT
K790126 · Holter-Hausner Intl. · Jan 1979