Cleared Traditional

K890329 - FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM

K890329 is an FDA 510(k) clearance for FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM, manufactured by Fresenius USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FIL cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K890329 · Fresenius USA, Inc. · Gastroenterology & Urology device
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May 1989
Decision
108d
Days
Class 2
Risk

K890329 is an FDA 510(k) clearance for the FRESENIUS 2008 BSS BEDSIDE DIALYSIS SYSTEM. Classified as System, Dialysate Delivery, Single Pass (product code FIL), Class II - Special Controls.

Submitted by Fresenius USA, Inc. (Concord, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 108 days - within the typical 510(k) review window.

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 Fresenius USA, Inc. devices

FDA 510(k) Submission Details - K890329

510(k) Number K890329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date May 11, 1989
Days to Decision 108 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 130d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIL Device Classification - Class 2, Special Controls

Product Code FIL System, Dialysate Delivery, Single Pass
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 - FIL System, Dialysate Delivery, Single Pass

Devices cleared under the same product code (FIL) and FDA review panel - the closest regulatory comparables to K890329.
SPS 550-IPS (INTEGRATED PATIENT STATION)
K901038 · Baxter Healthcare Corp · Apr 1990
ULTRAFILTRATION SCALE
K781633 · Extracorporeal Medical Specialities, Inc. · Dec 1978
ULTRAFILTRATION MONITOR 5M9034
K771875 · Travenol Laboratories, S.A. · Nov 1977
AK-10
K771227 · Gambro, Inc. · Aug 1977
NEGATIVE PRESSURE ADAPTER 5M1350
K770137 · Travenol Laboratories, S.A. · Feb 1977