Cleared Traditional

K873155 - GAMBRO BICART SYSTEM

K873155 is an FDA 510(k) clearance for GAMBRO BICART SYSTEM, 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 77-day FDA review.

K873155 · Gambro, Inc. · Gastroenterology & Urology device
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Oct 1987
Decision
77d
Days
Class 2
Risk

K873155 is an FDA 510(k) clearance for the GAMBRO BICART SYSTEM. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on October 26, 1987 after a review of 77 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 - K873155

510(k) Number K873155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1987
Decision Date October 26, 1987
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
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 K873155.
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
MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT
K871218 · Hospal Medical Corp. · Apr 1987
GAMBRO FLUID CONTROL MONITOR FCM 10-1
K864094 · Gambro, Inc. · Nov 1986
GAMBRO BICARBONATE MONITOR BCM 10-2
K864083 · Gambro, Inc. · Nov 1986