Cleared Traditional

K895759 - HOLLOW FIBER DIALYZER SERIES FOCUS 160/...

K895759 is the FDA 510(k) clearance for HOLLOW FIBER DIALYZER SERIES FOCUS 160/... by National Medical Care, Medical Products Div., Inc.. It is a Class 2 Gastroenterology & Urology device (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
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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

Submission Details

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
87d faster than avg
Panel avg: 130d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 198
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K895759.
QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q
K903641 · Bentley Laboratories, Inc. · Nov 1990
HOLLOW FIBER DIALYZER, BIO CARE PS 130
K900018 · National Medical Care, Medical Products Div., Inc. · Jul 1990
GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER
K900918 · Gambro, Inc. · Jul 1990
FILTRAL TM 20 HEMODIALYZER/FILTER
K893742 · Hospal Medical Corp. · Jul 1989
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
K892262 · Fresenius USA, Inc. · Apr 1989
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
K890315 · Baxter Healthcare Corp · Feb 1989