Cleared Traditional

K970700 - FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX (FDA 510(k) Clearance)

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

K970700 · Fresenius USA, Inc. · Gastroenterology & Urology device
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Sep 1998
Decision
567d
Days
Class 2
Risk

K970700 is an FDA 510(k) clearance for the FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX. Classified as Hemodialyzer, Re-use, Low Flux (product code MSE), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on September 15, 1998 after a review of 567 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 Fresenius USA, Inc. devices

Submission Details

510(k) Number K970700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1997
Decision Date September 15, 1998
Days to Decision 567 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
437d slower than avg
Panel avg: 130d · This submission: 567d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSE Hemodialyzer, Re-use, Low Flux
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.