Cleared Traditional

K911603 - HEMOSPAL KIT B22

K911603 is an FDA 510(k) clearance for HEMOSPAL KIT B22, manufactured by C.G.H. Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K911603

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
12d faster than avg
Panel avg: 131d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

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 311
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K911603.
FRESENIUS POLYSULFONE DIALYZERS
K921134 · Fresenius USA, Inc. · Dec 1993
PERITONEAL DIALYSIS CYCLER SET
K914363 · National Medical Care, Medical Products Div., Inc. · Mar 1992
DUO-FLUX(R) ULTRA HIGH PERFORM ARTIFICIAL KIDNEY
K913950 · Althin Medical AB an Affiliate of Baxter Intl · Nov 1991
INPERSOL CAPD BIOCAP ADMINISTRATION SET
K911094 · Abbott Laboratories · Apr 1991
RENAFLO HDF 1350 HEMODIAFILTER
K910236 · Minntech Corp. · Apr 1991
QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q
K903641 · Bentley Laboratories, Inc. · Nov 1990