Cleared Traditional

K895721 - MILLAR MIKRO-TIP PULSE TRANSDUCER

K895721 is the FDA 510(k) clearance for MILLAR MIKRO-TIP PULSE TRANSDUCER by Millar Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DXO) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K895721 · Millar Instruments, Inc. · Cardiovascular device
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Dec 1989
Decision
73d
Days
Class 2
Risk

K895721 is an FDA 510(k) clearance for the MILLAR MIKRO-TIP PULSE TRANSDUCER. Classified as Transducer, Pressure, Catheter Tip (product code DXO), Class II - Special Controls.

Submitted by Millar Instruments, Inc. (Houston, US). The FDA issued a Cleared decision on December 7, 1989 after a review of 73 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 Millar Instruments, Inc. devices

Submission Details

510(k) Number K895721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1989
Decision Date December 07, 1989
Days to Decision 73 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 125d · This submission: 73d
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 25
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K895721.
WIRELESS PHYSIOLOGIC MONITORING SYSTEM
K053016 · Edwards Lifesciences, LLC · Dec 2005
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
SENTORR ARTERIAL PRESSURE SENSOR
K880830 · Ohmeda Medical · Aug 1988
VITALERT 2000 VITAL SIGNS MONITOR
K882031 · Draeger Medical, Inc. · Jul 1988