Cleared Traditional

K770735 - DIALYZER

K770735 is the FDA 510(k) clearance for DIALYZER by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code FHS) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K770735 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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May 1977
Decision
19d
Days
Class 2
Risk

K770735 is an FDA 510(k) clearance for the DIALYZER, COIL, CD, LSA, 5M1765. Classified as Dialyzer, Single Coil (product code FHS), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on May 10, 1977 after a review of 19 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 K770735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1977
Decision Date May 10, 1977
Days to Decision 19 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
111d faster than avg
Panel avg: 130d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FHS Dialyzer, Single Coil
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 - FHS Dialyzer, Single Coil

All 10
Devices cleared under the same product code (FHS) and FDA review panel - the closest regulatory comparables to K770735.
DIALYZER, CD-800 COIL
K790223 · Travenol Laboratories, S.A. · Mar 1979
DIALYZER, DISP., COIL, LUNDIA
K781102 · Gambro, Inc. · Oct 1978
MODIFICATION TO KIDNEY DIALYZER
K771349 · Erika, Inc. · Aug 1977
COIL DIALYZER MODEL ALT 140
K761358 · Bentley Laboratories, Inc. · Jan 1977
ERI-FLO 900 DIALYZER
K760702 · Erika, Inc. · Nov 1976
DIALYZER (MODEL 1850)
K760374 · Erika, Inc. · Oct 1976