Cleared Traditional

K864703 - MODIFIED GAS-STAT(TM) MONITORING SYSTEM (FDA 510(k) Clearance)

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

K864703 · Cardiovascular Devices, Inc. · Cardiovascular device
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Feb 1987
Decision
79d
Days
Class 2
Risk

K864703 is an FDA 510(k) clearance for the MODIFIED GAS-STAT(TM) MONITORING SYSTEM. Classified as Sensor, Blood-gas, In-line, Cardiopulmonary Bypass (product code DTY), Class II - Special Controls.

Submitted by Cardiovascular Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on February 19, 1987 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4410 - 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 Cardiovascular Devices, Inc. devices

Submission Details

510(k) Number K864703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1986
Decision Date February 19, 1987
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTY Sensor, Blood-gas, In-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4410
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.