Cleared Traditional

K760702 - ERI-FLO 900 DIALYZER

K760702 is an FDA 510(k) clearance for ERI-FLO 900 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 58-day FDA review.

K760702 · Erika, Inc. · Gastroenterology & Urology device
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Nov 1976
Decision
58d
Days
Class 2
Risk

K760702 is an FDA 510(k) clearance for the ERI-FLO 900 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 November 19, 1976 after a review of 58 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 - K760702

510(k) Number K760702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1976
Decision Date November 19, 1976
Days to Decision 58 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
72d faster than avg
Panel avg: 130d · This submission: 58d
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.