Cleared Traditional

K862716 - HEMOFILTRATION SYSTEM 10 (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862716 · Gambro, Inc. · Gastroenterology & Urology device
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Sep 1986
Decision
54d
Days
Class 2
Risk

K862716 is an FDA 510(k) clearance for the HEMOFILTRATION SYSTEM 10. Classified as System, Dialysate Delivery, Sealed (product code FII), Class II - Special Controls.

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on September 9, 1986 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 Gambro, Inc. devices

Submission Details

510(k) Number K862716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1986
Decision Date September 09, 1986
Days to Decision 54 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
76d faster than avg
Panel avg: 130d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FII System, Dialysate Delivery, Sealed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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.