Cleared Traditional

INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER (K924737) - FDA 510(k) Clearance

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

K924737 · Becton Dickinson Vascular Access, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
335d
Days
Class 2
Risk

K924737 is an FDA 510(k) clearance for the INNERSENSE(TM) DISPOSABLE MICROTRANSDUCER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Becton Dickinson Vascular Access, Inc. (Sandy, US). The FDA issued a Cleared decision on August 23, 1993 after a review of 335 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 Becton Dickinson Vascular Access, Inc. devices

Submission Details

510(k) Number K924737 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1992
Decision Date August 23, 1993
Days to Decision 335 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
210d slower than avg
Panel avg: 125d · This submission: 335d
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 16
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K924737.
TruWave Disposable Pressure Transducer
K171996 · Edwards Lifesciences, LLC · Oct 2017
Comet Pressure Guidewire
K151610 · Boston Scientific Corporation · Oct 2015
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