Cleared Traditional

K951094 - POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM

K951094 is an FDA 510(k) clearance for POINT-OF-CARE ARTERIAL BLOOD GAS MONITO..., manufactured by Optical Sensors, Inc.. The device is a Class 2 Anesthesiology device with product code CCC cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K951094 · Optical Sensors, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
313d
Days
Class 2
Risk

K951094 is an FDA 510(k) clearance for the POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM. Classified as Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling (product code CCC), Class II - Special Controls.

Submitted by Optical Sensors, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 16, 1996 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1150 - 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 Optical Sensors, Inc. devices

FDA 510(k) Submission Details - K951094

510(k) Number K951094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1995
Decision Date January 16, 1996
Days to Decision 313 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 140d · This submission: 313d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCC Device Classification - Class 2, Special Controls

Product Code CCC Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1150
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 - CCC Analyzer, Gas, Carbon-dioxide, Partial Pressure, Blood-phase, Indwelling

All 11
Devices cleared under the same product code (CCC) and FDA review panel - the closest regulatory comparables to K951094.
PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
K953893 · Biomedical Sensors, Inc. · Nov 1997
POINT-OF-CARE BLOOD GAS MONITOR SYSTEM
K961790 · Optical Sensors, Inc. · Apr 1997
OLYMPUS CRITICAL CARE MONITORING SYSTEM
K963935 · Optical Sensors, Inc. · Jan 1997
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
K901548 · Shiley, Inc. · Jan 1991
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING
K891013 · Medtronic Vascular · Aug 1989
INDWELLING BLOOD CARBONDIOXIDE PARTIAL PRES. ANALY
K870911 · American Bentley · May 1987