Cleared Traditional

ULTRASONIC COUPLANT GEL (K854996) - FDA 510(k) Clearance

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

K854996 · Johnson & Johnson Professionals, Inc. · Cardiovascular device
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Apr 1986
Decision
123d
Days
Class 2
Risk

K854996 is an FDA 510(k) clearance for the ULTRASONIC COUPLANT GEL. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Ramsey, US). The FDA issued a Cleared decision on April 14, 1986 after a review of 123 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K854996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1985
Decision Date April 14, 1986
Days to Decision 123 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
2d faster than avg
Panel avg: 125d · This submission: 123d
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 12
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K854996.
RT5000 ECHOCARDIOGRAPHY #H4100C/CE
K870726 · General Electric Co. · Oct 1987
MERIDIAN IMAGING SYSTEM
K861737 · Johnson & Johnson Professionals, Inc. · Jul 1986
ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS
K860652 · Hewlett-Packard Co. · May 1986
MERIDIAN ULTRASOUND IMAGING SYSTEM
K853240 · Johnson & Johnson Professionals, Inc. · Feb 1986
Q-DOP
K843058 · Quinton, Inc. · Apr 1985
CARDIAC SECTOR PROBE 3.5. MHZ
K850145 · Siemens Medical Solutions USA, Inc. · Apr 1985