Cleared Traditional

K896757 - GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS

K896757 is an FDA 510(k) clearance for GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS, 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 272-day FDA review.

K896757 · Gambro, Inc. · Gastroenterology & Urology device
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Aug 1990
Decision
272d
Days
Class 2
Risk

K896757 is an FDA 510(k) clearance for the GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Gambro, Inc. (Williamsburg, US). The FDA issued a Cleared decision on August 30, 1990 after a review of 272 days - an extended review 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: 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K896757

510(k) Number K896757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date August 30, 1990
Days to Decision 272 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
142d slower than avg
Panel avg: 130d · This submission: 272d
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 K896757.
COBE CENTRY 2 BICART OPTION KIT
K905793 · Cobe Laboratories, Inc. · Feb 1991
COBE CENTRYSYSTEM 3 BICART OPTION KIT
K905388 · Cobe Laboratories, Inc. · Feb 1991
GAMBRO BICARBONATE MONITOR BCM 10-3
K896758 · Gambro, Inc. · Sep 1990
HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB
K894838 · Baxter Healthcare Corp · Sep 1989
FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM
K890824 · Fresenius USA, Inc. · May 1989
HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650
K883111 · Baxter Healthcare Corp · Feb 1989