Cleared Traditional

5 MHZ TRANSDUCER (K872074) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K872074 · Sonicaid, Inc. · Cardiovascular device
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Aug 1987
Decision
88d
Days
Class 2
Risk

K872074 is an FDA 510(k) clearance for the 5 MHZ TRANSDUCER. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Sonicaid, Inc. (Fredericksburg, US). The FDA issued a Cleared decision on August 25, 1987 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sonicaid, Inc. devices

Submission Details

510(k) Number K872074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1987
Decision Date August 25, 1987
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 16
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K872074.
UST-2266U-5 CW DOPPLER TRANSDUCER
K905369 · Ge Medical Systems Information Technologies · Feb 1991
TRANSESOPHAGEAL ECHO TRANSDUCER
K883889 · General Electric Co. · Nov 1988
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
K870726 · General Electric Co. · Oct 1987
SSD-725 ULTRASOUND SECTOR SCANNER
K870607 · Ge Medical Systems Information Technologies · Aug 1987
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.
K870916 · Ge Medical Systems Information Technologies · Jul 1987
MERIDIAN IMAGING SYSTEM
K861737 · Johnson & Johnson Professionals, Inc. · Jul 1986