Cleared Traditional

K812575 - MODEL H12-10

K812575 is an FDA 510(k) clearance for MODEL H12-10, manufactured by Hospal Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K812575

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
91d faster than avg
Panel avg: 131d · This submission: 40d
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 294
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K812575.
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HEMOFILTERS
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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