Cleared Traditional

K802030 - U.I. OCTOSON

K802030 is an FDA 510(k) clearance for U.I. OCTOSON, manufactured by Ausonics Pty , Ltd.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K802030 · Ausonics Pty , Ltd. · Cardiovascular device
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Oct 1980
Decision
43d
Days
Class 2
Risk

K802030 is an FDA 510(k) clearance for the U.I. OCTOSON. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Ausonics Pty , Ltd. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 43 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 Ausonics Pty , Ltd. devices

FDA 510(k) Submission Details - K802030

510(k) Number K802030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1980
Decision Date October 03, 1980
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

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 40
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K802030.
DC-1 CARDIAC IMAGING MODULE
K811556 · Diasonics, Inc. · Jul 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802917 · Advanced Technology Laboratories, Inc. · Jan 1981
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670 · American Edwards Laboratories · Nov 1980
ULTRA IMAGER
K800553 · Honeywell, Inc. · Jul 1980
LINEAR ARRAY SCANNER
K800805 · Philips Medical Systems (Cleveland), Inc. · Jul 1980
CATHODE RAY TUBE DISPLAY MODEL 1340A
K780332 · Hewlett-Packard Co. · Mar 1978