Cleared Traditional

K800536 - MODEL H 607-.67M2 30 MICRON RP AN69 MEM

K800536 is the FDA 510(k) clearance for MODEL H 607-.67M2 30 MICRON RP AN69 MEM by Hospal Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K800536 · Hospal Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1980
Decision
150d
Days
Class 2
Risk

K800536 is an FDA 510(k) clearance for the MODEL H 607-.67M2 30 MICRON RP AN69 MEM. 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 August 7, 1980 after a review of 150 days - an extended review 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: 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 K800536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1980
Decision Date August 07, 1980
Days to Decision 150 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
20d slower than avg
Panel avg: 130d · This submission: 150d
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 K800536.
GAMBRO LUNDIA PLATE HIGH FLUX HEMODIAL-
K801479 · Gambro, Inc. · Aug 1980
GAMBRO LUNDIA MAJOR HIGH FLUX HEMODIALYZ
K801480 · Gambro, Inc. · Aug 1980
C-DAK DUO-FLUX ARTIFICIAL KIDNEY
K801731 · Cordis Corp. · Aug 1980
RP-610 PARALLEL PLATE DIALYZER
K790827 · Hospal Medical Corp. · Sep 1979
CORTRAL I
K780527 · Hospal Medical Corp. · Dec 1978
HEMODIALYZER, MODEL RP610, RP AN 69
K781464 · Hospal Medical Corp. · Dec 1978