Cleared Traditional

K933883 - GAMBRO FH 66 D HEMOFILTER

K933883 is an FDA 510(k) clearance for GAMBRO FH 66 D HEMOFILTER, manufactured by Cobe Renal Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 580-day FDA review.

K933883 · Cobe Renal Care, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
580d
Days
Class 2
Risk

K933883 is an FDA 510(k) clearance for the GAMBRO FH 66 D HEMOFILTER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Cobe Renal Care, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 13, 1995 after a review of 580 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 Cobe Renal Care, Inc. devices

FDA 510(k) Submission Details - K933883

510(k) Number K933883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1993
Decision Date March 13, 1995
Days to Decision 580 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
450d slower than avg
Panel avg: 130d · This submission: 580d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K933883.
ALTRA FLUX(TM) 170 HEMODIALYZER
K945542 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
ALTRA FLUX(TM) 140 HEMODIALYZER
K945620 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950522 · Baxter Healthcare Corp · Apr 1995
ALTREX(R) 200 HEMODIALYZER
K945595 · Althin Medical AB an Affiliate of Baxter Intl · Mar 1995
ALTRES(R) 140 HEMODIALYZER
K945596 · Althin Medical AB an Affiliate of Baxter Intl · Mar 1995
ALTRES(R) 170 HEMODIALYZER
K945597 · Althin Medical AB an Affiliate of Baxter Intl · Mar 1995