Cleared Traditional

BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM (K884063) - FDA 510(k) Clearance

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

K884063 · C.R. Bard, Inc. · Anesthesiology device
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Dec 1988
Decision
81d
Days
Class 2
Risk

K884063 is an FDA 510(k) clearance for the BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on December 16, 1988 after a review of 81 days - a notably fast clearance cycle.

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: 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K884063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1988
Decision Date December 16, 1988
Days to Decision 81 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
59d faster than avg
Panel avg: 140d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (CCE) and FDA review panel - the closest regulatory comparables to K884063.
TISSUE OXYGEN MONITOR SYSTEM, MODEL II
K890624 · Baxter Healthcare Corp · Dec 1989
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
K895149 · Shiley, Inc. · Nov 1989
CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING
K895150 · Shiley, Inc. · Nov 1989
UMBILICAL ARTERY OXYGEN SENSOR
K875225 · Ohmeda Medical · Mar 1988
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM
K872125 · C.R. Bard, Inc. · Dec 1987