Cleared Traditional

K982337 - CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER

K982337 is an FDA 510(k) clearance for CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIA..., manufactured by Haidylena Medical Egypt. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K982337 · Haidylena Medical Egypt · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
176d
Days
Class 2
Risk

K982337 is an FDA 510(k) clearance for the CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Haidylena Medical Egypt (Nasr City, Cairo, EG). The FDA issued a Cleared decision on December 29, 1998 after a review of 176 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 Haidylena Medical Egypt devices

FDA 510(k) Submission Details - K982337

510(k) Number K982337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1998
Decision Date December 29, 1998
Days to Decision 176 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 131d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

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 117
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K982337.
A-18 HEMODIALYZER
K992565 · Althin Medical AB · Sep 1999
ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
K991512 · Asahi Medical Co., Ltd. · Jul 1999
DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111
K990159 · Dynamic Technology Corp. · Apr 1999
ULTRACON ULTRAFILTRATOR
K981253 · Interpore Intl. · Dec 1998
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658 · Baxter Healthcare Corp · May 1998
ULTRACON ULTRAFILTRATOR
K971710 · Quantic Biomedical, Inc. · Feb 1998