Cleared Traditional

K874084 - MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAK...

K874084 is the FDA 510(k) clearance for MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAK... by National Medical Care, Medical Products Div., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKQ) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K874084 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Apr 1988
Decision
203d
Days
Class 2
Risk

K874084 is an FDA 510(k) clearance for the MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by National Medical Care, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on April 27, 1988 after a review of 203 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 National Medical Care, Medical Products Div., Inc. devices

Submission Details

510(k) Number K874084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1987
Decision Date April 27, 1988
Days to Decision 203 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
73d slower than avg
Panel avg: 130d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKQ System, Dialysate Delivery, Central Multiple Patient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FKQ System, Dialysate Delivery, Central Multiple Patient

All 31
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K874084.
TWO TANK DISSOLUTION MODULE
K893612 · National Medical Care, Medical Products Div., Inc. · Jul 1989
ACTRIL FOR KIDNEY MACHINE DISINFECTANT
K861730 · Renal Systems, Inc. · Jun 1987
FOUR TANK DISSOLUTION MODULE
K864635 · National Medical Care, Medical Products Div., Inc. · Jan 1987
MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445
K861472 · National Medical Care, Medical Products Div., Inc. · Jul 1986
NATURALYTE BICARBONATE CONCENTRATE-DRY PACK
K852310 · Erika, Inc. · Jul 1985
NEPHROSS ALLEGRO H.F.
K844748 · Organon Teknika Corp. · Jan 1985