Cleared Traditional

K781405 - SUITCASE KIDNEY HEMODIALYSIS SYSTEM

K781405 is an FDA 510(k) clearance for SUITCASE KIDNEY HEMODIALYSIS SYSTEM, manufactured by Union Carbide Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FKP cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K781405 · Union Carbide Corp. · Gastroenterology & Urology device
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Dec 1978
Decision
115d
Days
Class 2
Risk

K781405 is an FDA 510(k) clearance for the SUITCASE KIDNEY HEMODIALYSIS SYSTEM. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1978 after a review of 115 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Union Carbide Corp. devices

FDA 510(k) Submission Details - K781405

510(k) Number K781405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1978
Decision Date December 07, 1978
Days to Decision 115 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
15d faster than avg
Panel avg: 130d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKP Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K781405.
GAMBRO AK-10-UDM-10-A ULTRADIFFUSION
K800425 · Gambro, Inc. · Apr 1980
MODELS DM-360 & DM-350-L SINGLE PATIENT
K792173 · Extracorporeal Medical Specialities, Inc. · Nov 1979
DIALYSATE DELIVERY SYSTEM
K781886 · Cordis Corp. · Jan 1979
SINGLE PATIENT SYSTEMS
K780682 · Extracorporeal Medical Specialities, Inc. · Jun 1978
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