Cleared Traditional

K874165 - DISPOSABLE CATHETER PRESSURE TRANSDUCER

K874165 is the FDA 510(k) clearance for DISPOSABLE CATHETER PRESSURE TRANSDUCER by Deseret Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXO) cleared through the Traditional 510(k) pathway after a 240-day FDA review.

K874165 · Deseret Medical, Inc. · Cardiovascular device
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Jun 1988
Decision
240d
Days
Class 2
Risk

K874165 is an FDA 510(k) clearance for the DISPOSABLE CATHETER PRESSURE TRANSDUCER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Deseret Medical, Inc. (Sandy, US). The FDA issued a Cleared decision on June 9, 1988 after a review of 240 days - an extended review cycle.

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. Standard predicate reliance. 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 Deseret Medical, Inc. devices

Submission Details

510(k) Number K874165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date June 09, 1988
Days to Decision 240 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d slower than avg
Panel avg: 125d · This submission: 240d
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 26
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K874165.
ULTRASONIC IMAGING CATHETER
K883202 · Boston Scientific Corp · Nov 1988
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · Ohmeda Medical · Aug 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · Draeger Medical, Inc. · Jul 1988
MODEL P23XL PHYSIOLOGICAL PRESSURE TRANSDUCER
K843969 · Gould, Inc. · Jan 1985
VSM R1
K842213 · Physio-Control Corp. · Oct 1984
BP TRANSDUCER HOLDERS TH-2,3 & 4
K832384 · American Bentley · Nov 1983