Cleared Traditional

K901592 - MODEL MD-5 DOPPLER

K901592 is the FDA 510(k) clearance for MODEL MD-5 DOPPLER by D. E. Hokanson, Inc.. It is a Class 2 Cardiovascular device (product code DXK) cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K901592 · D. E. Hokanson, Inc. · Cardiovascular device
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Oct 1990
Decision
200d
Days
Class 2
Risk

K901592 is an FDA 510(k) clearance for the MODEL MD-5 DOPPLER. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by D. E. Hokanson, Inc. (Bellevue, US). The FDA issued a Cleared decision on October 22, 1990 after a review of 200 days - an extended review cycle.

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 D. E. Hokanson, Inc. devices

Submission Details

510(k) Number K901592 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1990
Decision Date October 22, 1990
Days to Decision 200 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 125d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 40
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K901592.
ACCESSORY TO GENESIS III (GCFM)
K913209 · Biosound, Inc. · May 1992
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
K910029 · Spacelabs, Inc. · Jan 1991
ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND
K901657 · Hitachi Medical Corp. of America · Sep 1990
ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND
K901658 · Hitachi Medical Corp. of America · Sep 1990
DOPPLER OPTION FOR PLATINUM
K900002 · Philips Medical Systems North America, Inc. · Apr 1990