Cleared Traditional

K812209 - ULTRA COM

K812209 is an FDA 510(k) clearance for ULTRA COM, manufactured by Ultranamics, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K812209 · Ultranamics, Inc. · Cardiovascular device
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Nov 1981
Decision
104d
Days
Class 2
Risk

K812209 is an FDA 510(k) clearance for the ULTRA COM. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Ultranamics, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 104 days - within the typical 510(k) review window.

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: 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 Ultranamics, Inc. devices

FDA 510(k) Submission Details - K812209

510(k) Number K812209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1981
Decision Date November 16, 1981
Days to Decision 104 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 125d · This submission: 104d
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 47
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K812209.
DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
K844896 · Del Mar Avionics · Jun 1985
CARDIOSCAN - TM BEING APPLIED FOR
K841263 · Interspec, Inc. · Oct 1984
MAVIS C
K813002 · Philips Medical Systems (Cleveland), Inc. · Mar 1982
SKI 5000
K812646 · Smithkline Diagnostics, Inc. · Nov 1981
DC-1 CARDIAC IMAGING MODULE
K811556 · Diasonics, Inc. · Jul 1981
MARK III ULTRASONIC SCANNING SYSTEM
K802917 · Advanced Technology Laboratories, Inc. · Jan 1981