Cleared Traditional

K833728 - CARDIAC WALL MOTION DEVICE

K833728 is an FDA 510(k) clearance for CARDIAC WALL MOTION DEVICE, manufactured by Intl. Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K833728 · Intl. Medical, Inc. · Cardiovascular device
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Feb 1984
Decision
108d
Days
Class 2
Risk

K833728 is an FDA 510(k) clearance for the CARDIAC WALL MOTION DEVICE. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Intl. Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 10, 1984 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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 Intl. Medical, Inc. devices

FDA 510(k) Submission Details - K833728

510(k) Number K833728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1983
Decision Date February 10, 1984
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
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.