Cleared Traditional

K873032 - GENESIS II

K873032 is an FDA 510(k) clearance for GENESIS II, 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 198-day FDA review.

K873032 · Biosound, Inc. · Cardiovascular device
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Feb 1988
Decision
198d
Days
Class 2
Risk

K873032 is an FDA 510(k) clearance for the GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 198 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 - K873032

510(k) Number K873032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date February 18, 1988
Days to Decision 198 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
73d slower than avg
Panel avg: 125d · This submission: 198d
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 K873032.
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217 · Ge Medical Systems Information Technologies · Apr 1988
EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
K870878 · Hitachi Medical Corp. of America · Apr 1988
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
GENESIS II
K871697 · Biosound, Inc. · Nov 1987
MULTIPLE
K863387 · Del Mar Avionics · Sep 1987