Cleared Traditional

K875205 - TRI-FLOW CATHETER

K875205 is an FDA 510(k) clearance for TRI-FLOW CATHETER, manufactured by Neurodynamics, Inc.. The device is a Class 2 Neurology device with product code JXG cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K875205 · Neurodynamics, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
165d
Days
Class 2
Risk

K875205 is an FDA 510(k) clearance for the TRI-FLOW CATHETER. Classified as Shunt, Central Nervous System And Components (product code JXG), Class II - Special Controls.

Submitted by Neurodynamics, Inc. (New York, US). The FDA issued a Cleared decision on May 31, 1988 after a review of 165 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Neurodynamics, Inc. devices

FDA 510(k) Submission Details - K875205

510(k) Number K875205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1987
Decision Date May 31, 1988
Days to Decision 165 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 148d · This submission: 165d
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 225
Devices cleared under the same product code (JXG) and FDA review panel - the closest regulatory comparables to K875205.
PMT MANKIND LUMBAR-PERITONEAL SHUNT MODEL 1115-1
K881616 · Progress Mankind Technology · Sep 1988
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
K883114 · Pmt Corp. · Aug 1988
H-H FLUSHING RESERVOIR
K875287 · Holter-Hausner Intl. · Jul 1988
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
K874508 · Holter-Hausner Intl. · Jan 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