Cleared Traditional

MODIFICATIONS TO SERIES OF CARDIAC CATHETERS (K913042) - FDA 510(k) Clearance

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

K913042 · Sentron, Inc. · Cardiovascular device
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Oct 1992
Decision
484d
Days
Class 2
Risk

K913042 is an FDA 510(k) clearance for the MODIFICATIONS TO SERIES OF CARDIAC CATHETERS. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Sentron, Inc. (Federal Way, US). The FDA issued a Cleared decision on October 21, 1992 after a review of 484 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Sentron, Inc. devices

Submission Details

510(k) Number K913042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1991
Decision Date October 21, 1992
Days to Decision 484 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
359d slower than avg
Panel avg: 125d · This submission: 484d
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 18
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K913042.
TruWave Disposable Pressure Transducer
K142749 · Edwards Lifesciences, LLC · Jan 2015
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER
K141495 · Edwards Lifesciences, LLC · Sep 2014
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