Cleared Traditional

K790533 - HD CAPILLARY FILM DIALYZER

K790533 is the FDA 510(k) clearance for HD CAPILLARY FILM DIALYZER by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code FJG) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K790533 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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May 1979
Decision
48d
Days
Class 2
Risk

K790533 is an FDA 510(k) clearance for the HD CAPILLARY FILM DIALYZER, MODEL 1001. Classified as Dialyzer, Parallel Flow (product code FJG), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1979 after a review of 48 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 Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K790533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1979
Decision Date May 02, 1979
Days to Decision 48 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
82d faster than avg
Panel avg: 130d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (FJG) and FDA review panel - the closest regulatory comparables to K790533.
GAMBRO LUNDIA PLATE DIALYZER
K792611 · Gambro, Inc. · Feb 1980
EXTRACORPOREAL'S MODEL EX-85 DIALYZER
K791961 · Extracorporeal Medical Specialities, Inc. · Nov 1979
HEMODIALYZERS RP-510 AND RP-514
K791448 · Hospal Medical Corp. · Aug 1979
DIALYZER, MODEL F.M.D 150
K790001 · Hospal Medical Corp. · Mar 1979
DIALYZER, MAGNIFLO 100 PARALLEL PLATE
K781966 · Erika, Inc. · Feb 1979
LUNDIA PLATE DISPOSABLE DIALYZER
K780700 · Gambro, Inc. · Jul 1978