Cleared Traditional

TRANSDUCER, PRESSURE, CATHETER TIP (K920580) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 63
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K920580.
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