Cleared Traditional

K862304 - DRAKE WILLOCK CENTRAL DIALYSATE DELIVER...

K862304 is the FDA 510(k) clearance for DRAKE WILLOCK CENTRAL DIALYSATE DELIVER... by Cd Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FKQ) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K862304 · Cd Medical, Inc. · Gastroenterology & Urology device
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Sep 1986
Decision
84d
Days
Class 2
Risk

K862304 is an FDA 510(k) clearance for the DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM. Classified as System, Dialysate Delivery, Central Multiple Patient (product code FKQ), Class II - Special Controls.

Submitted by Cd Medical, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on September 9, 1986 after a review of 84 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 Cd Medical, Inc. devices

Submission Details

510(k) Number K862304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1986
Decision Date September 09, 1986
Days to Decision 84 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
46d faster than avg
Panel avg: 130d · This submission: 84d
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 32
Devices cleared under the same product code (FKQ) and FDA review panel - the closest regulatory comparables to K862304.
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K861472 · National Medical Care, Medical Products Div., Inc. · Jul 1986
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