Cleared Traditional

K860938 - GAMBRO FIBER HEMOFILTERS FH 22/66 DISPO...

K860938 is an FDA 510(k) clearance for GAMBRO FIBER HEMOFILTERS FH 22/66 DISPO..., manufactured by Gambro, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K860938 · Gambro, Inc. · Gastroenterology & Urology device
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Apr 1986
Decision
26d
Days
Class 2
Risk

K860938 is an FDA 510(k) clearance for the GAMBRO FIBER HEMOFILTERS FH 22/66 DISPOS TUBE SETS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on April 7, 1986 after a review of 26 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 Gambro, Inc. devices

FDA 510(k) Submission Details - K860938

510(k) Number K860938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1986
Decision Date April 07, 1986
Days to Decision 26 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
104d faster than avg
Panel avg: 130d · This submission: 26d
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 226
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K860938.
GAMBRO POLYFLUX 130 AND 160 HEMODIALYZER
K871108 · Gambro, Inc. · May 1987
HOSPAL BIOSPAL 1800S
K863961 · Hospal Medical Corp. · Dec 1986
HIGH EFFICIENCY HEMODIALYSIS SYSTEM
K861776 · Travenol Laboratories, S.A. · Jun 1986
GAMBRO BLOOD CONCENTRATOR SETS 16,60,200
K854309 · Gambro, Inc. · Dec 1985
HOLLOW FIBER DIALYZER
K854586 · Travenol Laboratories, S.A. · Dec 1985
RENALFO HEMOFILTER CAVHD
K854011 · Renal Systems, Inc. · Nov 1985