Cleared Traditional

K770867 - DIALYZER, FIBER, HOLLOW

K770867 is an FDA 510(k) clearance for DIALYZER, manufactured by Cobe Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K770867

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.

FJI Device Classification - Class 2, Special Controls

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 105
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K770867.
C-DAK 4000 ARTIFICIAL KIDNEY
K781058 · Cordis Corp. · Aug 1978
SPIRAFLOW DIALYZERS
K772423 · Bentley Laboratories, Inc. · Jan 1978
CLIRANS TH 15 HOLLOW FIBER DIALYZER
K771694 · Terumo America, Inc. · Sep 1977
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