Cleared Traditional

K771349 - MODIFICATION TO KIDNEY DIALYZER

K771349 is an FDA 510(k) clearance for MODIFICATION TO KIDNEY DIALYZER, manufactured by Erika, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FHS cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K771349 · Erika, Inc. · Gastroenterology & Urology device
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Aug 1977
Decision
12d
Days
Class 2
Risk

K771349 is an FDA 510(k) clearance for the MODIFICATION TO KIDNEY DIALYZER. Classified as Dialyzer, Single Coil (product code FHS), Class II - Special Controls.

Submitted by Erika, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1977 after a review of 12 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 Erika, Inc. devices

FDA 510(k) Submission Details - K771349

510(k) Number K771349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1977
Decision Date August 02, 1977
Days to Decision 12 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 130d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FHS Device Classification - Class 2, Special Controls

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 K771349.
GAMBRO LUNDIA COIL DIALYZER
K800174 · Gambro, Inc. · Feb 1980
DIALYZER, CD-800 COIL
K790223 · Travenol Laboratories, S.A. · Mar 1979
DIALYZER, DISP., COIL, LUNDIA
K781102 · Gambro, Inc. · Oct 1978
DIALYZER, COIL, CD, LSA, 5M1765
K770735 · Travenol Laboratories, S.A. · May 1977
COIL DIALYZER MODEL ALT 140
K761358 · Bentley Laboratories, Inc. · Jan 1977
ERI-FLO 900 DIALYZER
K760702 · Erika, Inc. · Nov 1976