Cleared Traditional

K791857 - HOLLOW FIBER DIALIZER MODEL TRIEX-3 (FDA 510(k) Clearance)

K791857 · Extracorporeal Medical Specialities, Inc. · Gastroenterology & Urology device
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Nov 1979
Decision
47d
Days
-
Risk

K791857 is an FDA 510(k) clearance for the HOLLOW FIBER DIALIZER MODEL TRIEX-3.

Submitted by Extracorporeal Medical Specialities, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1979 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel. 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

Submission Details

510(k) Number K791857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1979
Decision Date November 05, 1979
Days to Decision 47 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
83d faster than avg
Panel avg: 130d · This submission: 47d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -