Cleared Traditional

K873887 - MODIFIED HOLLOW FIBERS USED IN DIAFILTE...

K873887 is an FDA 510(k) clearance for MODIFIED HOLLOW FIBERS USED IN DIAFILTE..., manufactured by W.R. Grace & Co.-Conn.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K873887 · W.R. Grace & Co.-Conn. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 1987
Decision
77d
Days
Class 2
Risk

K873887 is an FDA 510(k) clearance for the MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by W.R. Grace & Co.-Conn. (Danvers, US). The FDA issued a Cleared decision on December 9, 1987 after a review of 77 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 W.R. Grace & Co.-Conn. devices

FDA 510(k) Submission Details - K873887

510(k) Number K873887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1987
Decision Date December 09, 1987
Days to Decision 77 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 130d · This submission: 77d
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 217
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K873887.
CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KIT
K883307 · Hospal Medical Corp. · Oct 1988
FRESENIUS F8 DIALYZER
K883195 · Fresenius USA, Inc. · Sep 1988
FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZER
K872767 · Hospal Medical Corp. · Dec 1987
HEMOCOR PLUS HEMOCONCENTRATOR
K872456 · Minntech Corp. · Sep 1987
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER
K871108 · Gambro, Inc. · May 1987
HOSPAL BIOSPAL 1800S
K863961 · Hospal Medical Corp. · Dec 1986