Cleared Traditional

K853138 - MILLAR MIKRO-TIP DOPPLER CATHETER

K853138 is the FDA 510(k) clearance for MILLAR MIKRO-TIP DOPPLER CATHETER by Millar Instruments, Inc.. It is a Class 2 Cardiovascular device (product code JOP) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K853138 · Millar Instruments, Inc. · Cardiovascular device
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Oct 1985
Decision
95d
Days
Class 2
Risk

K853138 is an FDA 510(k) clearance for the MILLAR MIKRO-TIP DOPPLER CATHETER. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Millar Instruments, Inc. (Houston, US). The FDA issued a Cleared decision on October 29, 1985 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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 K853138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1985
Decision Date October 29, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 27
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K853138.
ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS
K860652 · Hewlett-Packard Co. · May 1986
ULTRASONIC COUPLANT GEL
K854996 · Johnson & Johnson Professionals, Inc. · Apr 1986
MERIDIAN ULTRASOUND IMAGING SYSTEM
K853240 · Johnson & Johnson Professionals, Inc. · Feb 1986
Q-DOP
K843058 · Quinton, Inc. · Apr 1985
CARDIAC SECTOR PROBE 3.5. MHZ
K850145 · Siemens Medical Solutions USA, Inc. · Apr 1985
CARDIAC SECTOR PROBE 5.0 MHZ
K850216 · Siemens Medical Solutions USA, Inc. · Apr 1985