Cleared Traditional

K890492 - PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.

K890492 is an FDA 510(k) clearance for PRECEPT-PT(TM) MICROSENSOR PRESSURE MON..., manufactured by Endosonics Corp.. The device is a Class 2 Cardiovascular device with product code DXO cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K890492 · Endosonics Corp. · Cardiovascular device
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Mar 1989
Decision
30d
Days
Class 2
Risk

K890492 is an FDA 510(k) clearance for the PRECEPT-PT(TM) MICROSENSOR PRESSURE MONITOR CATH.. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Endosonics Corp. (Rancho Cordova, US). The FDA issued a Cleared decision on March 2, 1989 after a review of 30 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Endosonics Corp. devices

FDA 510(k) Submission Details - K890492

510(k) Number K890492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1989
Decision Date March 02, 1989
Days to Decision 30 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
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 53
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K890492.
MILLAR MIKRO-TIP PULSE TRANSDUCER
K895721 · Millar Instruments, Inc. · Dec 1989
DISPOSABLE CATHETER PRESSURE TRANSDUCER
K894033 · Deseret Medical, Inc. · Oct 1989
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K894286 · Ppg Industries, Inc. · Oct 1989
ULTRASONIC IMAGING CATHETER
K883202 · Boston Scientific Corp · Nov 1988
PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER
K883436 · Ppg Industries, Inc. · Oct 1988
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · Ohmeda Medical · Aug 1988