Cleared Traditional

K840009 - NOVA 12 CARDIAC OUTPUT COMPUTER

K840009 is an FDA 510(k) clearance for NOVA 12 CARDIAC OUTPUT COMPUTER, manufactured by Nova Medical Specialties. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K840009 · Nova Medical Specialties · Cardiovascular device
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Aug 1984
Decision
231d
Days
Class 2
Risk

K840009 is an FDA 510(k) clearance for the NOVA 12 CARDIAC OUTPUT COMPUTER. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Nova Medical Specialties (Mchenry, US). The FDA issued a Cleared decision on August 22, 1984 after a review of 231 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Nova Medical Specialties devices

FDA 510(k) Submission Details - K840009

510(k) Number K840009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1984
Decision Date August 22, 1984
Days to Decision 231 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 125d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 117
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K840009.
ELECATH VENTRICULAR PACING THERMAL DILUTION CATH
K844022 · Electro-Catheter Corp. · Nov 1984
MODELS 78551A 78552A
K841256 · Hewlett-Packard Co. · Oct 1984
BAIM CORONARY SINUS FLOW CALCULATOR
K842831 · Electro-Catheter Corp. · Aug 1984
SYSTEM 5000
K833756 · Medical Graphics Corp. · Apr 1984
HEMODYNAMIC PLUG-IN MODULE 78551A
K833913 · Hewlett-Packard Co. · Mar 1984
CARDIAC OUTPUT SIGNAL ACQUISTION
K833914 · Hewlett-Packard Co. · Mar 1984