Cleared Traditional

K890624 - TISSUE OXYGEN MONITOR SYSTEM, MODEL II

K890624 is an FDA 510(k) clearance for TISSUE OXYGEN MONITOR SYSTEM, manufactured by Baxter Healthcare Corp. The device is a Class 2 Anesthesiology device with product code CCE cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K890624 · Baxter Healthcare Corp · Anesthesiology device
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Dec 1989
Decision
318d
Days
Class 2
Risk

K890624 is an FDA 510(k) clearance for the TISSUE OXYGEN MONITOR SYSTEM, MODEL II. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on December 22, 1989 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1200 - 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. Elevated predicate reliance profile. 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K890624

510(k) Number K890624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1989
Decision Date December 22, 1989
Days to Decision 318 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 140d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCE Device Classification - Class 2, Special Controls

Product Code CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1200
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 - CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

All 15
Devices cleared under the same product code (CCE) and FDA review panel - the closest regulatory comparables to K890624.
SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA
K912145 · S & W Medico Teknik · May 1992
TOPS NEEDLE TIP PROBE & PVC TIP PROBE
K910453 · Baxter Healthcare Corp · Aug 1991
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
K905397 · Puritan Bennett Corp. · May 1991
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
K895149 · Shiley, Inc. · Nov 1989
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING
K895150 · Shiley, Inc. · Nov 1989
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
K884063 · C.R. Bard, Inc. · Dec 1988