Cleared Traditional

K940601 - GAMBRO BICART 720G

K940601 is an FDA 510(k) clearance for GAMBRO BICART 720G, manufactured by C.G.H. Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPO cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K940601 · C.G.H. Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
40d
Days
Class 2
Risk

K940601 is an FDA 510(k) clearance for the GAMBRO BICART 720G. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by C.G.H. Medical, Inc. (Lakewood, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 40 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 C.G.H. Medical, Inc. devices

FDA 510(k) Submission Details - K940601

510(k) Number K940601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1994
Decision Date March 22, 1994
Days to Decision 40 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 131d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPO Device Classification - Class 2, Special Controls

Product Code KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)
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 - KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)

All 82
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K940601.
FRESENIUS DIALYSATE ACID CONCENTRATE
K922088 · Fresenius USA, Inc. · Oct 1994
HEMODIALYSIS BATH
K922990 · Medi-Tech, Inc. · Sep 1994
GRANULYTE DIALYSATE CONCENTRATE
K922005 · Fresenius USA, Inc. · Mar 1994
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
K911459 · Fresenius USA, Inc. · Jul 1991
PREMIXED DIALYSATE FOR HEMODIAFILTRATION
K910270 · Baxter Healthcare Corp · Apr 1991
ACETATE CONCENTRATES FOR HEMODIALYSIS
K905021 · Medical Components, Inc. · Mar 1991