Cleared Traditional

K896758 - GAMBRO BICARBONATE MONITOR BCM 10-3

K896758 is an FDA 510(k) clearance for GAMBRO BICARBONATE MONITOR BCM 10-3, 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 301-day FDA review.

K896758 · Gambro, Inc. · Gastroenterology & Urology device
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Sep 1990
Decision
301d
Days
Class 2
Risk

K896758 is an FDA 510(k) clearance for the GAMBRO BICARBONATE MONITOR BCM 10-3. 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 September 28, 1990 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K896758

510(k) Number K896758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date September 28, 1990
Days to Decision 301 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
171d slower than avg
Panel avg: 130d · This submission: 301d
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 K896758.
FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM
K921456 · Fresenius USA, Inc. · Apr 1994
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 AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS
K896757 · Gambro, Inc. · Aug 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