Cleared Traditional

K974090 - 95 C/1.5 CITRIC ACID HEAT PROCESSING OF...

K974090 is the FDA 510(k) clearance for 95 C/1.5 CITRIC ACID HEAT PROCESSING OF... by Fresenius Medical Care North America. It is a Class 2 Gastroenterology & Urology device (product code MSE) cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K974090 · Fresenius Medical Care North America · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
302d
Days
Class 2
Risk

K974090 is an FDA 510(k) clearance for the 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS. Classified as Hemodialyzer, Re-use, Low Flux (product code MSE), Class II - Special Controls.

Submitted by Fresenius Medical Care North America (Walnut Creek, US). The FDA issued a Cleared decision on August 27, 1998 after a review of 302 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Fresenius Medical Care North America devices

Submission Details

510(k) Number K974090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1997
Decision Date August 27, 1998
Days to Decision 302 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
172d slower than avg
Panel avg: 130d · This submission: 302d
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.

Regulatory Peers - MSE Hemodialyzer, Re-use, Low Flux

Devices cleared under the same product code (MSE) and FDA review panel - the closest regulatory comparables to K974090.
PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210
K001685 · Baxter Healthcare Corp · Nov 2000
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
K970700 · Fresenius USA, Inc. · Sep 1998
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970654 · Baxter Healthcare Corp · Nov 1997
CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90)
K970661 · Baxter Healthcare Corp · Nov 1997