Cleared Traditional

K870878 - EUB-305 DIAGNOSTIC ULTRASOUND DEVICE

K870878 is the FDA 510(k) clearance for EUB-305 DIAGNOSTIC ULTRASOUND DEVICE by Hitachi Medical Corp. of America. It is a Class 2 Cardiovascular device (product code DXK) cleared through the Traditional 510(k) pathway after a 415-day FDA review.

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
Combination Product No
PCCP Authorized No
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 39
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K870878.
GENESIS III, (MOD. 7003/7004)
K894370 · Biosound, Inc. · Jan 1990
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632 · Toshiba America Medical Systems, In.C · Oct 1989
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217 · Ge Medical Systems Information Technologies · Apr 1988
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
K871555 · General Electric Co. · Mar 1988
GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN
K873032 · Biosound, Inc. · Feb 1988
SERIES 77000 ULTRASOUND IMAGING SYSTEM
K873762 · Hewlett-Packard Co. · Feb 1988