Cleared Traditional

K812575 - MODEL H12-10

K812575 is the FDA 510(k) clearance for MODEL H12-10 by Hospal Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K812575 · Hospal Medical Corp. · Gastroenterology & Urology device
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Oct 1981
Decision
40d
Days
Class 2
Risk

K812575 is an FDA 510(k) clearance for the MODEL H12-10. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Hospal Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1981 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 876.5860 - 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: 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 Hospal Medical Corp. devices

Submission Details

510(k) Number K812575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1981
Decision Date October 19, 1981
Days to Decision 40 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
90d faster than avg
Panel avg: 130d · This submission: 40d
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 K812575.
COBE HEMOCONCENTRATOR 1.3
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H 12 07
K823589 · Hospal Medical Corp. · Dec 1982
CONTINUOUS BLOOD PROCESSOR CBP-6000 &
K820243 · Bentley Laboratories, Inc. · Mar 1982
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K811830 · Cordis Corp. · Sep 1981
GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER
K811944 · Gambro, Inc. · Aug 1981
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-
K801479 · Gambro, Inc. · Aug 1980