Cleared Traditional

K791961 - EXTRACORPOREAL'S MODEL EX-85 DIALYZER

K791961 is an FDA 510(k) clearance for EXTRACORPOREAL'S MODEL EX-85 DIALYZER, manufactured by Extracorporeal Medical Specialities, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJG cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K791961 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Nov 1979
Decision
43d
Days
Class 2
Risk

K791961 is an FDA 510(k) clearance for the EXTRACORPOREAL'S MODEL EX-85 DIALYZER. Classified as Dialyzer, Parallel Flow (product code FJG), Class II - Special Controls.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 43 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 Extracorporeal Medical Specialities, Inc. devices

FDA 510(k) Submission Details - K791961

510(k) Number K791961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1979
Decision Date November 13, 1979
Days to Decision 43 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
88d faster than avg
Panel avg: 131d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJG Device Classification - Class 2, Special Controls

Product Code FJG Dialyzer, Parallel Flow
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 - FJG Dialyzer, Parallel Flow

All 26
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K791961.
ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM
K801451 · Medical, Inc. · Sep 1980
LUNDIA PLATE DISP.
K800424 · Gambro, Inc. · Apr 1980
GAMBRO LUNDIA PLATE DIALYZER
K792611 · Gambro, Inc. · Feb 1980
HEMODIALYZERS RP-510 AND RP-514
K791448 · Hospal Medical Corp. · Aug 1979
HEMOCLEAR U-NEPHROS 1.0 DIALYZER
K790758 · Medical, Inc. · May 1979
HD CAPILLARY FILM DIALYZER, MODEL 1001
K790533 · Travenol Laboratories, S.A. · May 1979