Cleared Traditional

K853138 - MILLAR MIKRO-TIP DOPPLER CATHETER

K853138 is an FDA 510(k) clearance for MILLAR MIKRO-TIP DOPPLER CATHETER, manufactured by Millar Instruments, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K853138

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
Combination Product No
PCCP Authorized No
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.

JOP Device Classification - Class 2, Special Controls

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 53
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
DOPLETTE 10
K851269 · Imex Medical Systems, Inc. · Jul 1985
3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA
K851616 · Ausonics Pty , Ltd. · Jul 1985
Q-DOP
K843058 · Quinton, Inc. · Apr 1985