Cleared Traditional

K862859 - EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRA...

K862859 is an FDA 510(k) clearance for EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRA..., manufactured by Biosound, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K862859 · Biosound, Inc. · Cardiovascular device
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Feb 1987
Decision
188d
Days
Class 2
Risk

K862859 is an FDA 510(k) clearance for the EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 2, 1987 after a review of 188 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 Biosound, Inc. devices

FDA 510(k) Submission Details - K862859

510(k) Number K862859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1986
Decision Date February 02, 1987
Days to Decision 188 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
63d slower than avg
Panel avg: 125d · This submission: 188d
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 39
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K862859.
GENESIS II
K871697 · Biosound, Inc. · Nov 1987
MULTIPLE
K863387 · Del Mar Avionics · Sep 1987
SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING
K871400 · Ge Medical Systems Information Technologies · Jul 1987
ATL'S ULTRAMARK 6 ULTRASOUND SYSTEM
K864657 · Advanced Technology Laboratories, Inc. · Feb 1987
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
K861710 · Johnson & Johnson Professionals, Inc. · Jul 1986
SONOLAYER S, SSH-60A/SDS-60A
K853115 · Toshiba Medical Systems · Mar 1986