Cleared Traditional

K913042 - MODIFICATIONS TO SERIES OF CARDIAC CATHETERS

K913042 is an FDA 510(k) clearance for MODIFICATIONS TO SERIES OF CARDIAC CATH..., manufactured by Sentron, Inc.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 484-day FDA review.

K913042 · Sentron, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K913042

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.

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 58
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K913042.
PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600
K925638 · Baxter Healthcare Corp · Oct 1993
INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER
K924737 · Becton Dickinson Vascular Access, Inc. · Aug 1993
TRANSDUCER, PRESSURE, CATHETER TIP
K920580 · Medamicus, Inc. · Jan 1993
MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN
K915775 · Millar Instruments, Inc. · Apr 1992
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429 · Baxter Healthcare Corp · Jul 1991
MILLAR MIKRO-TIP PULSE TRANSDUCER
K895721 · Millar Instruments, Inc. · Dec 1989