Cleared Traditional

K871212 - MASCOT CW DOPPLER SYSTEM

K871212 is an FDA 510(k) clearance for MASCOT CW DOPPLER SYSTEM, manufactured by Imex Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K871212 · Imex Medical Systems, Inc. · Cardiovascular device
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Aug 1987
Decision
141d
Days
Class 2
Risk

K871212 is an FDA 510(k) clearance for the MASCOT CW DOPPLER SYSTEM. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Imex Medical Systems, Inc. (Golden, US). The FDA issued a Cleared decision on August 14, 1987 after a review of 141 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 Imex Medical Systems, Inc. devices

FDA 510(k) Submission Details - K871212

510(k) Number K871212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1987
Decision Date August 14, 1987
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
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 38
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K871212.
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
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ACUSON L538 TRANSDUCER
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K870607 · Ge Medical Systems Information Technologies · Aug 1987
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K870150 · Cardio Metrics, Inc. · Aug 1987
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.
K870916 · Ge Medical Systems Information Technologies · Jul 1987