Cleared Traditional

K925654 - CD HOME DIALYSERVICE HEMODIALYSIS TRAY

K925654 is the FDA 510(k) clearance for CD HOME DIALYSERVICE HEMODIALYSIS TRAY by Cd Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 506-day FDA review.

K925654 · Cd Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
506d
Days
Class 2
Risk

K925654 is an FDA 510(k) clearance for the CD HOME DIALYSERVICE HEMODIALYSIS TRAY. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Cd Medical, Inc. (Miami Lakes, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 506 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Cd Medical, Inc. devices

Submission Details

510(k) Number K925654 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received November 09, 1992
Decision Date March 30, 1994
Days to Decision 506 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
376d slower than avg
Panel avg: 130d · This submission: 506d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 116
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K925654.
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