Cleared Traditional

MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY (K861710) - FDA 510(k) Clearance

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

K861710 · Johnson & Johnson Professionals, Inc. · Cardiovascular device
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Jul 1986
Decision
65d
Days
Class 2
Risk

K861710 is an FDA 510(k) clearance for the MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Ramsey, US). The FDA issued a Cleared decision on July 9, 1986 after a review of 65 days - a notably fast clearance 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: 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 Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K861710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1986
Decision Date July 09, 1986
Days to Decision 65 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
60d faster than avg
Panel avg: 125d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K861710.
MODEL SSH-140A ULTRASOUND IMAGING SYSTEM
K894632 · Toshiba America Medical Systems, In.C · Oct 1989
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
SONOLINE SX ULTRASOUND SCANNER
K852739 · Siemens Medical Solutions USA, Inc. · Mar 1986
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · Hewlett-Packard Co. · Oct 1985
MAVIS C
K813002 · Philips Medical Systems (Cleveland), Inc. · Mar 1982