Cleared Traditional

K930503 - CLIRANS WET PACK HOLLOW FIBER DIALYZER

K930503 is an FDA 510(k) clearance for CLIRANS WET PACK HOLLOW FIBER DIALYZER, manufactured by Terumo Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 763-day FDA review.

K930503 · Terumo Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
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Mar 1995
Decision
763d
Days
Class 2
Risk

K930503 is an FDA 510(k) clearance for the CLIRANS WET PACK HOLLOW FIBER DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on March 6, 1995 after a review of 763 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Terumo Medical Corp. devices

FDA 510(k) Submission Details - K930503

510(k) Number K930503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date March 06, 1995
Days to Decision 763 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
633d slower than avg
Panel avg: 130d · This submission: 763d
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 97
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K930503.
MCA(TM) 160 HEMODIALYZER
K945624 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
155 SCE(TM) HEMODIALYZER
K945631 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950454 · Baxter Healthcare Corp · Apr 1995
MCA 200 HEMPDIALYZER
K926372 · Althin Medical AB an Affiliate of Baxter Intl · Feb 1995
BAXTER CA DIALYZER
K926567 · Baxter Healthcare Corp · Jan 1995
FRESENIUS HEMOFLOW, VARIOUS MODELS
K926005 · Fresenius USA, Inc. · Aug 1994