Cleared Traditional

K881723 - GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER

K881723 is an FDA 510(k) clearance for GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER, manufactured by Biosound, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K881723 · Biosound, Inc. · Cardiovascular device
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Aug 1988
Decision
113d
Days
Class 2
Risk

K881723 is an FDA 510(k) clearance for the GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Biosound, Inc. (Indianapolis, US). The FDA issued a Cleared decision on August 12, 1988 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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 - K881723

510(k) Number K881723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1988
Decision Date August 12, 1988
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 29
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K881723.
RESUBMITTAL OF MI 1000C MICROIMAGER
K881979 · Ausonics Pty , Ltd. · Jun 1989
TRANSESOPHAGEAL ECHO TRANSDUCER
K883889 · General Electric Co. · Nov 1988
SDU-700 PHASED ARRAY SECTOR AND LINEAR SCANNER
K873674 · Shimadzu Corp. · Oct 1988
BIOSOUND MMI ULTRASOUND
K871442 · Biosound, Inc. · May 1988
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
K870726 · General Electric Co. · Oct 1987
SSD-725 ULTRASOUND SECTOR SCANNER
K870607 · Ge Medical Systems Information Technologies · Aug 1987