Cleared Traditional

MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (K874084) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K874084 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 60
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K874084.
ST FAMILY OF HOLLOW FIBER DIALYZERS
K844756 · Travenol Laboratories, S.A. · Jan 1985
GAMMA STERIL. CAPILLARY FLOW DIALY-G15
K832663 · Travenol Laboratories, S.A. · Sep 1983
GAMMA STERILIZED CAPILLARY FLOW DIALYZ
K831940 · Travenol Laboratories, S.A. · Aug 1983
ALTERNATE STERILIZ. FOR CELLULOSE ACET
K810315 · Cordis Corp. · Mar 1981
DIALYZING FLUIDE DELIVERY SYSTEM
K780081 · Travenol Laboratories, S.A. · Mar 1978
PRESSURE MODULE 5M1247
K771375 · Travenol Laboratories, S.A. · Sep 1977