Cleared Traditional

K861866 - ACUSON L382 AND L312 TRANSDUCERS

K861866 is an FDA 510(k) clearance for ACUSON L382 AND L312 TRANSDUCERS, manufactured by Acuson Computed Sonography. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K861866 · Acuson Computed Sonography · Cardiovascular device
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Jul 1986
Decision
66d
Days
Class 2
Risk

K861866 is an FDA 510(k) clearance for the ACUSON L382 AND L312 TRANSDUCERS. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Acuson Computed Sonography (Mountain View, US). The FDA issued a Cleared decision on July 18, 1986 after a review of 66 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 Acuson Computed Sonography devices

FDA 510(k) Submission Details - K861866

510(k) Number K861866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1986
Decision Date July 18, 1986
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 36
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K861866.
ACUSON S519 TRANSDUCER
K861596 · Acuson Computed Sonography · Jul 1986
MERIDIAN IMAGING SYSTEM
K861737 · Johnson & Johnson Professionals, Inc. · Jul 1986
ACUSON S319 TRANSDUCER
K862159 · Acuson Computed Sonography · Jul 1986
ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS
K860652 · Hewlett-Packard Co. · May 1986
ULTRASONIC COUPLANT GEL
K854996 · Johnson & Johnson Professionals, Inc. · Apr 1986
MERIDIAN ULTRASOUND IMAGING SYSTEM
K853240 · Johnson & Johnson Professionals, Inc. · Feb 1986