Cleared Traditional

K911603 - HEMOSPAL KIT B22

K911603 is the FDA 510(k) clearance for HEMOSPAL KIT B22 by C.G.H. Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K911603 · C.G.H. Medical, Inc. · Gastroenterology & Urology device
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Aug 1991
Decision
119d
Days
Class 2
Risk

K911603 is an FDA 510(k) clearance for the HEMOSPAL KIT B22. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by C.G.H. Medical, Inc. (Lakewood, US). The FDA issued a Cleared decision on August 7, 1991 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 C.G.H. Medical, Inc. devices

Submission Details

510(k) Number K911603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1991
Decision Date August 07, 1991
Days to Decision 119 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
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 96
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K911603.
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
K963203 · Baxter Healthcare Corp · Mar 1997
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER
K950522 · Baxter Healthcare Corp · Apr 1995
BAXTER CT DIALYZER
K926568 · Baxter Healthcare Corp · Sep 1994
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · Abbott Laboratories · Apr 1991
GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER
K900918 · Gambro, Inc. · Jul 1990
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
K890315 · Baxter Healthcare Corp · Feb 1989