Cleared Traditional

K852885 - FILTRAL HEMODIALYZER

K852885 is an FDA 510(k) clearance for FILTRAL HEMODIALYZER, 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 59-day FDA review.

K852885 · Hospal Medical Corp. · Gastroenterology & Urology device
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Sep 1985
Decision
59d
Days
Class 2
Risk

K852885 is an FDA 510(k) clearance for the FILTRAL HEMODIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Hospal Medical Corp. (East Brunswick, US). The FDA issued a Cleared decision on September 6, 1985 after a review of 59 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 - K852885

510(k) Number K852885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1985
Decision Date September 06, 1985
Days to Decision 59 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
72d faster than avg
Panel avg: 131d · This submission: 59d
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 K852885.
HOLLOW FIBER DIALYZER
K854586 · Travenol Laboratories, S.A. · Dec 1985
RENALFO HEMOFILTER CAVHD
K854011 · Renal Systems, Inc. · Nov 1985
MINIFILTER HEMOFILTER
K853510 · Amicon, Inc. · Sep 1985
DIMENSION TOTAL HIP PROSTHESIS
K853333 · Kirschner Medical Corp. · Sep 1985
FRESENIUS HEMOFLOW F60 & FRESENIUS HEMOFLOW F40
K852251 · Seratronics, Inc. · Jul 1985
RENAFLO HEMOCONCENTRATOR
K844790 · Renal Systems, Inc. · May 1985