Cleared Traditional

K874084 - MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM

K874084 is an FDA 510(k) clearance for MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAK..., manufactured by National Medical Care, Medical Products Div., Inc.. The device is a Class 2 Gastroenterology & Urology device with 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

FDA 510(k) Submission Details - K874084

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
72d slower than avg
Panel avg: 131d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKQ Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K874084.
DIACAP ULTRA DIALYSIS FLUID FILTER
K052764 · B. Braun Medizintechnologie GmbH · Jun 2006
TWO TANK DISSOLUTION MODULE
K893612 · National Medical Care, Medical Products Div., Inc. · Jul 1989
KAWASUMI A.V. FISTULA SET
K873421 · Kawasumi Laboratories Co., Ltd. · Oct 1987
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