Cleared Traditional

K925638 - PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600

K925638 is an FDA 510(k) clearance for PHOENIX DISPOSABLE PRESSURE TRANSDUCER ..., manufactured by Baxter Healthcare Corp. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K925638 · Baxter Healthcare Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
343d
Days
Class 2
Risk

K925638 is an FDA 510(k) clearance for the PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on October 18, 1993 after a review of 343 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K925638

510(k) Number K925638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1992
Decision Date October 18, 1993
Days to Decision 343 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 125d · This submission: 343d
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 57
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K925638.
PRESSURE WIRE SENSOR, MODELS 12003/12303, 12004/12304
K022187 · Radi Medical Systems AB · Sep 2002
FLOW DIRECTED MIKRO-TIP PRESSURE TRANSDUCER
K935166 · Millar Instruments, Inc. · Aug 1994
INNERSENSE DISPOSABLE MICROTRANSDUCER
K941283 · Becton Dickinson Vascular Access, Inc. · Apr 1994
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