Cleared Traditional

K770867 - DIALYZER

K770867 is the FDA 510(k) clearance for DIALYZER by Cobe Laboratories, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K770867 · Cobe Laboratories, Inc. · Gastroenterology & Urology device
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Jun 1977
Decision
33d
Days
Class 2
Risk

K770867 is an FDA 510(k) clearance for the DIALYZER, FIBER, HOLLOW. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1977 after a review of 33 days - a notably fast clearance cycle.

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: 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 K770867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1977
Decision Date June 14, 1977
Days to Decision 33 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
97d faster than avg
Panel avg: 130d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJI Dialyzer, Capillary, Hollow Fiber
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 51
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K770867.
FLOW DIALYZER, CF 2300 CAPILLARY
K790067 · Travenol Laboratories, S.A. · Apr 1979
ARTIFICIAL KIDNEY, C-DAK 0.6D
K782151 · Cordis Corp. · Feb 1979
C-DAK 4000 ARTIFICIAL KIDNEY
K781058 · Cordis Corp. · Aug 1978
DIALYZER, FIBER, HOLLOW
K770734 · Travenol Laboratories, S.A. · May 1977
ARTIFICIAL KIDNEY, C-DAK CORDIS DOW
K761007 · Cordis Corp. · Jan 1977
DIALYZER, HF 130 HOLLOW FIBER
K760252 · Cobe Laboratories, Inc. · Oct 1976