Cleared Traditional

K994306 - REVERSO

K994306 is an FDA 510(k) clearance for REVERSO, 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.

K994306 · Medisystems Corp. · Gastroenterology & Urology device
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Mar 2000
Decision
90d
Days
Class 2
Risk

K994306 is an FDA 510(k) clearance for the REVERSO. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Medisystems Corp. (Seattle, US). The FDA issued a Cleared decision on March 20, 2000 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 - K994306

510(k) Number K994306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1999
Decision Date March 20, 2000
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 K994306.
FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9
K010268 · Fresenius Medical Care North America · Apr 2001
TRANSONIC HEMODIALYSIS FLOW REVERSER, MODEL B FLOWREV
K002816 · Transonic Systems, Inc. · Nov 2000
ACCESS ALERT GAUGE
K002372 · Medisystems Corp. · Oct 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
MEDISYSTEMS DIALYSIS PRIMING SETS
K971860 · Medisystems Corp. · Aug 1997