Cleared Traditional

K831185 - CARDIAC OUTPUT MEASURE SYSTEM

K831185 is the FDA 510(k) clearance for CARDIAC OUTPUT MEASURE SYSTEM by Cook, Inc.. It is a Class 2 Cardiovascular device (product code DYG) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K831185 · Cook, Inc. · Cardiovascular device
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May 1983
Decision
45d
Days
Class 2
Risk

K831185 is an FDA 510(k) clearance for the CARDIAC OUTPUT MEASURE SYSTEM. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Cook, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1983 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cook, Inc. devices

Submission Details

510(k) Number K831185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1983
Decision Date May 27, 1983
Days to Decision 45 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
80d faster than avg
Panel avg: 125d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 53
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K831185.
USCI ANGIOGRAPHIC BALLOON CATHETER
K831854 · C.R. Bard, Inc. · Oct 1983
FLOW-DIRECTED HEPARIN COATED THERMODIL
K832957 · Sorensen Research · Sep 1983
ELECATH BALTHERM TLC THERMAL DILUTION
K831945 · Electro-Catheter Corp. · Aug 1983
THERMAL DILUTION CATHETER
K823484 · Instrumentation Laboratory CO · Dec 1982
BALLOON THERMODILUTION CATHETER #7164&
K823433 · Critikon Company, LLC · Nov 1982
SWAN-GANZ BIPOLAR PACING CATHETER
K822723 · American Edwards Laboratories · Oct 1982