Cleared Traditional

EUB-305 DIAGNOSTIC ULTRASOUND DEVICE (K870878) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K870878 · Hitachi Medical Corp. of America · Cardiovascular device
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Apr 1988
Decision
415d
Days
Class 2
Risk

K870878 is an FDA 510(k) clearance for the EUB-305 DIAGNOSTIC ULTRASOUND DEVICE. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Hitachi Medical Corp. of America (Tarrytown, US). The FDA issued a Cleared decision on April 22, 1988 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Hitachi Medical Corp. of America devices

Submission Details

510(k) Number K870878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1987
Decision Date April 22, 1988
Days to Decision 415 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 125d · This submission: 415d
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 12
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K870878.
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
K160173 · Boston Scientific Corporation · Feb 2016
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632 · Toshiba America Medical Systems, In.C · Oct 1989
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
K871555 · General Electric Co. · Mar 1988
SERIES 77000 ULTRASOUND IMAGING SYSTEM
K873762 · Hewlett-Packard Co. · Feb 1988
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
K861710 · Johnson & Johnson Professionals, Inc. · Jul 1986