Cleared Traditional

K823338 - COBE HEMOCONCENTRATOR 1.3

K823338 is the FDA 510(k) clearance for COBE HEMOCONCENTRATOR 1.3 by Cobe Laboratories, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K823338 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
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Jan 1983
Decision
60d
Days
Class 2
Risk

K823338 is an FDA 510(k) clearance for the COBE HEMOCONCENTRATOR 1.3. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1983 after a review of 60 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K823338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1982
Decision Date January 07, 1983
Days to Decision 60 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
70d faster than avg
Panel avg: 130d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 94
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K823338.
HEMOFILTRATION SYSTEM
K831784 · Gambro, Inc. · Feb 1984
ULTRAFILTRATION MONITOR UFM-10-2
K830596 · Gambro, Inc. · Apr 1983
FH 101, FH 202 & FH 303 FIBER HEMOFILTER
K830284 · Gambro, Inc. · Mar 1983
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K811830 · Cordis Corp. · Sep 1981
GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
K811944 · Gambro, Inc. · Aug 1981
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-
K801479 · Gambro, Inc. · Aug 1980