Cleared Traditional

K904967 - HOSPAL BICART RETROFIT KIT NA/MONIT S G...

K904967 is an FDA 510(k) clearance for HOSPAL BICART RETROFIT KIT NA/MONIT S G..., manufactured by Gambro-Hosp-Cobe, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FKP cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K904967 · Gambro-Hosp-Cobe, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1991
Decision
84d
Days
Class 2
Risk

K904967 is an FDA 510(k) clearance for the HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL. Classified as System, Dialysate Delivery, Single Patient (product code FKP), Class II - Special Controls.

Submitted by Gambro-Hosp-Cobe, Inc. (Lakewood, US). The FDA issued a Cleared decision on January 28, 1991 after a review of 84 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-Hosp-Cobe, Inc. devices

FDA 510(k) Submission Details - K904967

510(k) Number K904967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1990
Decision Date January 28, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 130d · This submission: 84d
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 37
Devices cleared under the same product code (FKP) and FDA review panel - the closest regulatory comparables to K904967.
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 BICARBONATE MONITOR BCM 10-3
K896758 · Gambro, Inc. · Sep 1990
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