Cleared Traditional

K900918 - GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER

K900918 is an FDA 510(k) clearance for GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER, 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 139-day FDA review.

K900918 · Gambro, Inc. · Gastroenterology & Urology device
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Jul 1990
Decision
139d
Days
Class 2
Risk

K900918 is an FDA 510(k) clearance for the GAMBRO LUNDIA IC-6H PARALLEL PLATE DIALYZER. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Gambro, Inc. (Williamsburg, US). The FDA issued a Cleared decision on July 16, 1990 after a review of 139 days - within the typical 510(k) review window.

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 Gambro, Inc. devices

FDA 510(k) Submission Details - K900918

510(k) Number K900918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1990
Decision Date July 16, 1990
Days to Decision 139 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
9d slower than avg
Panel avg: 130d · This submission: 139d
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 K900918.
RENAFLO HDF 1350 HEMODIAFILTER
K910236 · Minntech Corp. · Apr 1991
QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q
K903641 · Bentley Laboratories, Inc. · Nov 1990
HOLLOW FIBER DIALYZER, BIO CARE PS 130
K900018 · National Medical Care, Medical Products Div., Inc. · Jul 1990
HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H
K895759 · National Medical Care, Medical Products Div., Inc. · Nov 1989
FILTRAL TM 20 HEMODIALYZER/FILTER
K893742 · Hospal Medical Corp. · Jul 1989
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
K892262 · Fresenius USA, Inc. · Apr 1989