Cleared Traditional

K823338 - COBE HEMOCONCENTRATOR 1.3

K823338 is an FDA 510(k) clearance for COBE HEMOCONCENTRATOR 1.3, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K823338

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.

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 246
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K823338.
H1207
K830648 · Hospal Medical Corp. · Mar 1983
FH 101, FH 202 & FH 303 FIBER HEMOFILTER
K830284 · Gambro, Inc. · Mar 1983
ARTERIOVENOUS BLOOD TUBING SET FOR
K823881 · Amicon, Inc. · Jan 1983
H 12 07
K823589 · Hospal Medical Corp. · Dec 1982
AMICON DIAFILTERS 20 & 30 HEMOFILTERS
K823288 · Amicon, Inc. · Dec 1982
HEMOFILTERS
K813591 · Amicon, Inc. · Mar 1982