Cleared Traditional

K851426 - ACCUCOM CARDIAC OUTPUT MONITOR

K851426 is the FDA 510(k) clearance for ACCUCOM CARDIAC OUTPUT MONITOR by Lawrence Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DXK) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

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.

Regulatory Peers - DXK Echocardiograph

All 19
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K851426.
MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY
K861710 · Johnson & Johnson Professionals, Inc. · Jul 1986
SONOLINE SX ULTRASOUND SCANNER
K852739 · Siemens Medical Solutions USA, Inc. · Mar 1986
IRREGULAR CURVE TRACING REVISITION & DOPPLER
K853769 · Hewlett-Packard Co. · Oct 1985
MAVIS C
K813002 · Philips Medical Systems (Cleveland), Inc. · Mar 1982
CONTIUOUS WAVE DOPPLER ULTRASOUND
K802670 · American Edwards Laboratories · Nov 1980
ULTRA IMAGER
K800553 · Honeywell, Inc. · Jul 1980