Cleared Traditional

K971860 - MEDISYSTEMS DIALYSIS PRIMING SETS

K971860 is an FDA 510(k) clearance for MEDISYSTEMS DIALYSIS PRIMING SETS, manufactured by Medisystems Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K971860 · Medisystems Corp. · Gastroenterology & Urology device
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Aug 1997
Decision
90d
Days
Class 2
Risk

K971860 is an FDA 510(k) clearance for the MEDISYSTEMS DIALYSIS PRIMING SETS. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Medisystems Corp. (Washington, US). The FDA issued a Cleared decision on August 18, 1997 after a review of 90 days - within the typical 510(k) review window.

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 Medisystems Corp. devices

FDA 510(k) Submission Details - K971860

510(k) Number K971860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1997
Decision Date August 18, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 131d · This submission: 90d
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 137
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K971860.
REVERSO
K994306 · Medisystems Corp. · Mar 2000
JMS DIALYZER PRIMING SET
K983707 · Jms Co., Ltd. · Jan 1999
NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
K972206 · Nipro Medical Corp. · Nov 1997
NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS
K954676 · Nissho Corp. · Mar 1997
CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS
K964041 · Robert R. Stevens · Jan 1997
ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS
K955277 · Baxter Healthcare Corp · Feb 1996