Cleared Traditional

K893612 - TWO TANK DISSOLUTION MODULE

K893612 is an FDA 510(k) clearance for TWO 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 75-day FDA review.

K893612 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Jul 1989
Decision
75d
Days
Class 2
Risk

K893612 is an FDA 510(k) clearance for the TWO 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 July 24, 1989 after a review of 75 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 - K893612

510(k) Number K893612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1989
Decision Date July 24, 1989
Days to Decision 75 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
56d faster than avg
Panel avg: 131d · This submission: 75d
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 K893612.
DIACAP ULTRA DIALYSIS FLUID FILTER
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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