Cleared Traditional

DIALYSIS DELIVERY SYS., ULTIM. MODEL II (K770350) - FDA 510(k) Clearance

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

K770350 · Vital Systems, Inc. · Gastroenterology & Urology device
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Mar 1977
Decision
14d
Days
Class 2
Risk

K770350 is an FDA 510(k) clearance for the DIALYSIS DELIVERY SYS., ULTIM. MODEL II. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Vital Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 8, 1977 after a review of 14 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 Vital Systems, Inc. devices

Submission Details

510(k) Number K770350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1977
Decision Date March 08, 1977
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKP System, Dialysate Delivery, Single Patient
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 - FKP System, Dialysate Delivery, Single Patient

All 9
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K770350.
MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM
K800330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
DIALYSATE DELIVERY SYSTEM
K781886 · Cordis Corp. · Jan 1979
EMODIALYSIS DEL. SYS. MODEL 7110
K771696 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1977
5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY
K761287 · Travenol Laboratories, S.A. · Jan 1977