Cleared Traditional

K941803 - PRISM MEDICAL CUSTOM DIALYSIS KIT

K941803 is an FDA 510(k) clearance for PRISM MEDICAL CUSTOM DIALYSIS KIT, manufactured by Medical Device Support Services. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K941803 · Medical Device Support Services · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
293d
Days
Class 2
Risk

K941803 is an FDA 510(k) clearance for the PRISM MEDICAL CUSTOM DIALYSIS KIT. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Medical Device Support Services (El Paso, US). The FDA issued a Cleared decision on January 30, 1995 after a review of 293 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Medical Device Support Services devices

FDA 510(k) Submission Details - K941803

510(k) Number K941803 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received April 12, 1994
Decision Date January 30, 1995
Days to Decision 293 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
163d slower than avg
Panel avg: 130d · This submission: 293d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

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 123
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K941803.
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
SILICONE CATHETER REPAIR KITS
K926374 · Akcess Medical Products, Inc. · Oct 1994
BARD UROTRACK II MONITORING
K924436 · C.R. Bard, Inc. · Mar 1994
RS-1000
K911230 · Cp Medical · Jun 1993