Cleared Traditional

K864635 - FOUR TANK DISSOLUTION MODULE

K864635 is an FDA 510(k) clearance for FOUR TANK DISSOLUTION MODULE, 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 49-day FDA review.

K864635 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
49d
Days
Class 2
Risk

K864635 is an FDA 510(k) clearance for the FOUR TANK DISSOLUTION MODULE. 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 January 13, 1987 after a review of 49 days - a notably fast clearance 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: 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 National Medical Care, Medical Products Div., Inc. devices

FDA 510(k) Submission Details - K864635

510(k) Number K864635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1986
Decision Date January 13, 1987
Days to Decision 49 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
82d faster than avg
Panel avg: 131d · This submission: 49d
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 K864635.
MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM
K874084 · National Medical Care, Medical Products Div., Inc. · Apr 1988
KAWASUMI A.V. FISTULA SET
K873421 · Kawasumi Laboratories Co., Ltd. · Oct 1987
ACTRIL FOR KIDNEY MACHINE DISINFECTANT
K861730 · Renal Systems, Inc. · Jun 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
FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD
K844750 · Seratronics, Inc. · Feb 1985