Cleared Traditional

K843643 - COLOR DOPPLER 880

K843643 is an FDA 510(k) clearance for COLOR DOPPLER 880, manufactured by Irex Corp.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K843643 · Irex Corp. · Cardiovascular device
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Jan 1985
Decision
136d
Days
Class 2
Risk

K843643 is an FDA 510(k) clearance for the COLOR DOPPLER 880. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Irex Corp. (Ramsey, US). The FDA issued a Cleared decision on January 31, 1985 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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 Irex Corp. devices

FDA 510(k) Submission Details - K843643

510(k) Number K843643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1984
Decision Date January 31, 1985
Days to Decision 136 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 125d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 47
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K843643.
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · Hewlett-Packard Co. · Oct 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · Kontron Instruments, Inc. · Sep 1985
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
K844896 · Del Mar Avionics · Jun 1985
CARDIOSCAN - TM BEING APPLIED FOR
K841263 · Interspec, Inc. · Oct 1984
MAVIS C
K813002 · Philips Medical Systems (Cleveland), Inc. · Mar 1982
SKI 5000
K812646 · Smithkline Diagnostics, Inc. · Nov 1981