Cleared Traditional

K935166 - FLOW DIRECTED MIKRO-TIP PRESSURE TRANSD...

K935166 is the FDA 510(k) clearance for FLOW DIRECTED MIKRO-TIP PRESSURE TRANSD... by Millar Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DXO) cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K935166 · Millar Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
282d
Days
Class 2
Risk

K935166 is an FDA 510(k) clearance for the FLOW DIRECTED MIKRO-TIP PRESSURE 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 August 5, 1994 after a review of 282 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 Millar Instruments, Inc. devices

Submission Details

510(k) Number K935166 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date August 05, 1994
Days to Decision 282 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 125d · This submission: 282d
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 K935166.
PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER
K113584 · St Jude Medical · Mar 2012
SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX
K070487 · Volcano Corporation · Mar 2007
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