Cleared Traditional

K941543 - DIAL MEDICAL KIT

K941543 is the FDA 510(k) clearance for DIAL MEDICAL KIT by Regulatory & Marketing Services, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K941543 · Regulatory & Marketing Services, Inc. · Gastroenterology & Urology device
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Feb 1995
Decision
323d
Days
Class 2
Risk

K941543 is an FDA 510(k) clearance for the DIAL MEDICAL KIT. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on February 16, 1995 after a review of 323 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Regulatory & Marketing Services, Inc. devices

Submission Details

510(k) Number K941543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received March 30, 1994
Decision Date February 16, 1995
Days to Decision 323 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
193d slower than avg
Panel avg: 130d · This submission: 323d
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 48
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K941543.
ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS
K955277 · Baxter Healthcare Corp · Feb 1996
DIALYSIS ADMINISTRATION KITS
K952572 · B.Braun Medical, Inc. · Jan 1996
KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA
K950282 · KARL STORZ Endoscopy-America, Inc. · Apr 1995
BARD UROTRACK II MONITORING
K924436 · C.R. Bard, Inc. · Mar 1994
BARD(R) UROTACK(R) 210 MONITORING SYSTEM
K912374 · C.R. Bard, Inc. · Mar 1992
EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
K911315 · Baxter Healthcare Corp · Oct 1991