Cleared Traditional

K903414 - TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN

K903414 is an FDA 510(k) clearance for TRANSESOPHAGEAL PROBE HOLDER & DISINFEC..., manufactured by Echo Ultrasound. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K903414 · Echo Ultrasound · Cardiovascular device
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Sep 1990
Decision
51d
Days
Class 2
Risk

K903414 is an FDA 510(k) clearance for the TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Echo Ultrasound (Reedsville, US). The FDA issued a Cleared decision on September 19, 1990 after a review of 51 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Echo Ultrasound devices

FDA 510(k) Submission Details - K903414

510(k) Number K903414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1990
Decision Date September 19, 1990
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
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 K903414.
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
K910029 · Spacelabs, Inc. · Jan 1991
INTERSPEC APOGEE
K903839 · Interspec, Inc. · Nov 1990
MODEL MD-5 DOPPLER
K901592 · D. E. Hokanson, Inc. · Oct 1990
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
CVIS INSIGHT IMAGING CATHETER
K901562 · Cardiovascular Imaging Systems, Inc. · Jul 1990