Cleared Traditional

FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER (K952343) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K952343 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
217d
Days
Class 2
Risk

K952343 is an FDA 510(k) clearance for the FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on December 22, 1995 after a review of 217 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all National Medical Care, Medical Products Div., Inc. devices

Submission Details

510(k) Number K952343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1995
Decision Date December 22, 1995
Days to Decision 217 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 130d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJI Dialyzer, Capillary, Hollow Fiber
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 130
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K952343.
Hemoflow F3 and F4 Dialyzers
K190459 · Fresenius Medical Care Renal Therapies Group, LLC · Aug 2019
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658 · Baxter Healthcare Corp · May 1998
PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER
K963933 · Baxter Healthcare Corp · Nov 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454 · Baxter Healthcare Corp · Apr 1995
BAXTER CA DIALYZER
K926567 · Baxter Healthcare Corp · Jan 1995
MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ
K905228 · Baxter Healthcare Corp · Dec 1990