Cleared Traditional

K884228 - CDI(R) 2000 BLOOD GAS MONITOR (FDA 510(k) Clearance)

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

K884228 · Cardiovascular Devices, Inc. · Anesthesiology device
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Jan 1989
Decision
115d
Days
Class 2
Risk

K884228 is an FDA 510(k) clearance for the CDI(R) 2000 BLOOD GAS MONITOR. Classified as Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling (product code CBZ), Class II - Special Controls.

Submitted by Cardiovascular Devices, Inc. (Irvine, US). The FDA issued a Cleared decision on January 30, 1989 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1170 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardiovascular Devices, Inc. devices

Submission Details

510(k) Number K884228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1988
Decision Date January 30, 1989
Days to Decision 115 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 139d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBZ Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1170
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 Anesthesiology devices follow this clearance model.