Cleared Traditional

K841152 - HOSPAL BIOSPAL SCU/CAVH KIT

K841152 is the FDA 510(k) clearance for HOSPAL BIOSPAL SCU/CAVH KIT by Hospal Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K841152 · Hospal Medical Corp. · Gastroenterology & Urology device
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Jul 1984
Decision
109d
Days
Class 2
Risk

K841152 is an FDA 510(k) clearance for the HOSPAL BIOSPAL SCU/CAVH KIT. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Hospal Medical Corp. (Walker, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 109 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 Hospal Medical Corp. devices

Submission Details

510(k) Number K841152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1984
Decision Date July 06, 1984
Days to Decision 109 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
21d faster than avg
Panel avg: 130d · This submission: 109d
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 187
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K841152.
RENAFLO HEMOCONCENTRATOR
K844790 · Renal Systems, Inc. · May 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L
K850866 · Erika, Inc. · Apr 1985
AMER. BENTLEY CONTINU-BLOOD PROCESSOR-
K841585 · American Bentley · Oct 1984
CENTRY 2000 DIALYSIS CONTROL UNIT
K840680 · Cobe Laboratories, Inc. · Apr 1984
BLOOD CONCENTRATOR 140
K840543 · Gambro, Inc. · Mar 1984
HEMOFILTRATION SYSTEM
K831784 · Gambro, Inc. · Feb 1984