Cleared Traditional

K871697 - GENESIS II

K871697 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 190-day FDA review.

K871697 · Biosound, Inc. · Cardiovascular device
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Nov 1987
Decision
190d
Days
Class 2
Risk

K871697 is an FDA 510(k) clearance for the GENESIS II. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on November 6, 1987 after a review of 190 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 - K871697

510(k) Number K871697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1987
Decision Date November 06, 1987
Days to Decision 190 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
65d slower than avg
Panel avg: 125d · This submission: 190d
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 K871697.
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
MULTIPLE
K863387 · Del Mar Avionics · Sep 1987
SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING
K871400 · Ge Medical Systems Information Technologies · Jul 1987
EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND
K862859 · Biosound, Inc. · Feb 1987