Cleared Traditional

K822000 - EXTRACORPOREAL BLOOD GAS SYSTEM

K822000 is an FDA 510(k) clearance for EXTRACORPOREAL BLOOD GAS SYSTEM, manufactured by Cardiovascular Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DTY cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K822000 · Cardiovascular Devices, Inc. · Cardiovascular device
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Dec 1982
Decision
168d
Days
Class 2
Risk

K822000 is an FDA 510(k) clearance for the EXTRACORPOREAL BLOOD GAS SYSTEM. Classified as Sensor, Blood-gas, In-line, Cardiopulmonary Bypass (product code DTY), Class II - Special Controls.

Submitted by Cardiovascular Devices, Inc. (Walker, US). The FDA issued a Cleared decision on December 22, 1982 after a review of 168 days - an extended review 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: 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 Cardiovascular Devices, Inc. devices

FDA 510(k) Submission Details - K822000

510(k) Number K822000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1982
Decision Date December 22, 1982
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTY Device Classification - Class 2, Special Controls

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.