Cleared Traditional

K851426 - ACCUCOM CARDIAC OUTPUT MONITOR (FDA 510(k) Clearance)

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

K851426 · Lawrence Medical Systems, Inc. · Cardiovascular device
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Jul 1985
Decision
93d
Days
Class 2
Risk

K851426 is an FDA 510(k) clearance for the ACCUCOM CARDIAC OUTPUT MONITOR. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Lawrence Medical Systems, Inc. (Redmond, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 93 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 Lawrence Medical Systems, Inc. devices

Submission Details

510(k) Number K851426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1985
Decision Date July 12, 1985
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.