Cleared Traditional

K781805 - CARDIAC COMPUTERS, CO-10 & CO-10R

K781805 is an FDA 510(k) clearance for CARDIAC COMPUTERS, manufactured by Waters Assoc., Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K781805 · Waters Assoc., Inc. · Cardiovascular device
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Jan 1979
Decision
97d
Days
Class 2
Risk

K781805 is an FDA 510(k) clearance for the CARDIAC COMPUTERS, CO-10 & CO-10R. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Waters Assoc., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 29, 1979 after a review of 97 days - within the typical 510(k) review window.

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 Waters Assoc., Inc. devices

FDA 510(k) Submission Details - K781805

510(k) Number K781805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1978
Decision Date January 29, 1979
Days to Decision 97 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 125d · This submission: 97d
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 112
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K781805.
CARDIAC OUTPUT COMPUTER, M-MLC-4100
K792678 · Nihon Kohden America, Inc. · Jan 1980
MODEL 656 ARRHYTHMIA ANALYZER
K792080 · Del Mar Avionics · Dec 1979
STORAGE, DIGITAL DSC-1, CONTROL UNIT
K790288 · Oxford Medilog, Inc. · Feb 1979
LVV OPTION
K781855 · Honeywell, Inc. · Jan 1979
CENTRAL MONITORING SYSTEM
K772152 · Burdick Corp. · Nov 1977
LIGHT-PEN SYSTEM FOR QUANTI. ANALY.
K772158 · Varian Assoc., Inc. · Nov 1977