Cleared Traditional

K913483 - MINNILERT PRESSURE MONITOR

K913483 is the FDA 510(k) clearance for MINNILERT PRESSURE MONITOR by Minntech Corp.. It is a Class 2 Gastroenterology & Urology device (product code KOC) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K913483 · Minntech Corp. · Gastroenterology & Urology device
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Sep 1991
Decision
52d
Days
Class 2
Risk

K913483 is an FDA 510(k) clearance for the MINNILERT(R) PRESSURE MONITOR. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Minntech Corp. (Minneapolis, US). The FDA issued a Cleared decision on September 27, 1991 after a review of 52 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 Minntech Corp. devices

Submission Details

510(k) Number K913483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1991
Decision Date September 27, 1991
Days to Decision 52 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
78d faster than avg
Panel avg: 130d · This submission: 52d
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 83
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K913483.
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EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT
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K911106 · Baxter Healthcare Corp · May 1991
MODIFIED LABELING TO MODEL 9608 ARTERIAL HEMO BLD.
K895244 · National Medical Care, Medical Products Div., Inc. · Feb 1990
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K896006 · Baxter Healthcare Corp · Dec 1989