Cleared Traditional

K895759 - HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H

K895759 is an FDA 510(k) clearance for HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H, manufactured by National Medical Care, Medical Products Div., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K895759 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
43d
Days
Class 2
Risk

K895759 is an FDA 510(k) clearance for the HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on November 8, 1989 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology 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 National Medical Care, Medical Products Div., Inc. devices

FDA 510(k) Submission Details - K895759

510(k) Number K895759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date November 08, 1989
Days to Decision 43 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 131d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 298
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K895759.
GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER
K900918 · Gambro, Inc. · Jul 1990
AMICON HEMOCONCENTRATOR SET
K901286 · Amicon, Inc. · May 1990
AMICON MINIFILTER PLUS HEMOFILTER
K895405 · Amicon, Inc. · Jan 1990
FILTRAL TM 20 HEMODIALYZER/FILTER
K893742 · Hospal Medical Corp. · Jul 1989
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
K892262 · Fresenius USA, Inc. · Apr 1989
TORAY FILTRYZER BK SERIES
K883407 · Toray Industries (America), Inc. · Feb 1989