Cleared Traditional

K851616 - 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA (FDA 510(k) Clearance)

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

K851616 · Ausonics Pty , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
102d
Days
Class 2
Risk

K851616 is an FDA 510(k) clearance for the 3.5. MHZ PROBE FOR AUSONICS 150 & 357 REAL TIME CA. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Ausonics Pty , Ltd. (Suffield, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 102 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 Ausonics Pty , Ltd. devices

Submission Details

510(k) Number K851616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1985
Decision Date July 29, 1985
Days to Decision 102 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 125d · This submission: 102d
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.