Cleared Traditional

K002372 - ACCESS ALERT GAUGE

K002372 is an FDA 510(k) clearance for ACCESS ALERT GAUGE, 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 82-day FDA review.

K002372 · Medisystems Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
82d
Days
Class 2
Risk

K002372 is an FDA 510(k) clearance for the ACCESS ALERT GAUGE. 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 October 25, 2000 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medisystems Corp. devices

FDA 510(k) Submission Details - K002372

510(k) Number K002372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2000
Decision Date October 25, 2000
Days to Decision 82 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
49d faster than avg
Panel avg: 131d · This submission: 82d
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 K002372.
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
K081043 · Nxstage Medical, Inc. · Jul 2008
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
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