Cleared Traditional

K884228 - CDI(R) 2000 BLOOD GAS MONITOR

K884228 is an FDA 510(k) clearance for CDI 2000 BLOOD GAS MONITOR, manufactured by Cardiovascular Devices, Inc.. The device is a Class 2 Anesthesiology device with product code CBZ cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K884228 · Cardiovascular Devices, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K884228

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
25d faster than avg
Panel avg: 140d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CBZ Analyzer, Ion, Hydrogen-ion (ph), Blood-phase, Indwelling

All 8
Devices cleared under the same product code (CBZ) and FDA review panel - the closest regulatory comparables to K884228.
HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM
K920061 · Abbott Laboratories · Mar 1992
CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED
K912030 · 3M Company · Oct 1991
PB3300 SENSING CATHETER FOR CONTINUOUS MEASUREMENT
K912428 · Puritan Bennett Corp. · Aug 1991
SENSOMAT MUSCLE/TISSUE PH
K803260 · Biochem International, Inc. · Feb 1981
SENSOMAT
K803014 · Biochem International, Inc. · Dec 1980