Cleared Traditional

K895721 - MILLAR MIKRO-TIP PULSE TRANSDUCER

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

K895721 · Millar Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K895721

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
Combination Product No
PCCP Authorized No
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.

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 55
Devices cleared under the same product code (DXO) and FDA review panel - the closest regulatory comparables to K895721.
TRANSDUCER, PRESSURE, CATHETER TIP
K920580 · Medamicus, Inc. · Jan 1993
MILLAR NONMAGNECTIC MIKRO-TIP CATHETER PRESS. TRAN
K915775 · Millar Instruments, Inc. · Apr 1992
SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER
K910429 · Baxter Healthcare Corp · Jul 1991
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