Cleared Traditional

K920580 - TRANSDUCER

K920580 is an FDA 510(k) clearance for TRANSDUCER, manufactured by Medamicus, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K920580 · Medamicus, Inc. · Cardiovascular device
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Jan 1993
Decision
332d
Days
Class 2
Risk

K920580 is an FDA 510(k) clearance for the TRANSDUCER, PRESSURE, CATHETER TIP. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Medamicus, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 7, 1993 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2870 - the FDA cardiovascular device oversight 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medamicus, Inc. devices

FDA 510(k) Submission Details - K920580

510(k) Number K920580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1992
Decision Date January 07, 1993
Days to Decision 332 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 125d · This submission: 332d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXO Device Classification - Class 2, Special Controls

Product Code DXO Transducer, Pressure, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2870
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DXO Transducer, Pressure, Catheter Tip

All 27
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K920580.
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
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WIRELESS PHYSIOLOGIC MONITORING SYSTEM
K053016 · Edwards Lifesciences, LLC · Dec 2005
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
K925638 · Baxter Healthcare Corp · Oct 1993
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429 · Baxter Healthcare Corp · Jul 1991
ULTRASONIC IMAGING CATHETER
K883202 · Boston Scientific Corp · Nov 1988
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · Ohmeda Medical · Aug 1988