Cleared Traditional

K873989 - DOPPLEX ULTRASONIC DOPPLER SYSTEM

K873989 is an FDA 510(k) clearance for DOPPLEX ULTRASONIC DOPPLER SYSTEM, manufactured by Ultramed, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K873989 · Ultramed, Inc. · Cardiovascular device
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Mar 1988
Decision
154d
Days
Class 2
Risk

K873989 is an FDA 510(k) clearance for the DOPPLEX ULTRASONIC DOPPLER SYSTEM. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Ultramed, Inc. (North Brunswick, US). The FDA issued a Cleared decision on March 2, 1988 after a review of 154 days - an extended review cycle.

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 Ultramed, Inc. devices

FDA 510(k) Submission Details - K873989

510(k) Number K873989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1987
Decision Date March 02, 1988
Days to Decision 154 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 125d · This submission: 154d
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 55
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K873989.
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
K873674 · Shimadzu Corp. · Oct 1988
GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER
K881723 · Biosound, Inc. · Aug 1988
BIOSOUND MMI ULTRASOUND
K871442 · Biosound, Inc. · May 1988
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
K870726 · General Electric Co. · Oct 1987
AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER
K871416 · Acuson Computed Sonography · Sep 1987
ACUSON L538 TRANSDUCER
K871506 · Acuson Computed Sonography · Sep 1987