Cleared Traditional

K800425 - GAMBRO AK-10-UDM-10-A ULTRADIFFUSION

K800425 is an FDA 510(k) clearance for GAMBRO AK-10-UDM-10-A ULTRADIFFUSION, manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKP cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K800425 · Gambro, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1980
Decision
42d
Days
Class 2
Risk

K800425 is an FDA 510(k) clearance for the GAMBRO AK-10-UDM-10-A ULTRADIFFUSION. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Gambro, Inc. (Walker, US). The FDA issued a Cleared decision on April 8, 1980 after a review of 42 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K800425

510(k) Number K800425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1980
Decision Date April 08, 1980
Days to Decision 42 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
88d faster than avg
Panel avg: 130d · This submission: 42d
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 K800425.
EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS
K802880 · Extracorporeal Medical Specialities, Inc. · Dec 1980
DIALYSIS CONTROL UNIT-CENTRY 2000
K802250 · Cobe Laboratories, Inc. · Dec 1980
MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM
K800330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · 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
SUITCASE KIDNEY HEMODIALYSIS SYSTEM
K781405 · Union Carbide Corp. · Dec 1978