Cleared Traditional

K963935 - OLYMPUS CRITICAL CARE MONITORING SYSTEM

K963935 is an FDA 510(k) clearance for OLYMPUS CRITICAL CARE MONITORING SYSTEM, 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 114-day FDA review.

K963935 · Optical Sensors, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
114d
Days
Class 2
Risk

K963935 is an FDA 510(k) clearance for the OLYMPUS CRITICAL CARE 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 23, 1997 after a review of 114 days - within the typical 510(k) review window.

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. 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 Optical Sensors, Inc. devices

FDA 510(k) Submission Details - K963935

510(k) Number K963935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1996
Decision Date January 23, 1997
Days to Decision 114 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 140d · This submission: 114d
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 K963935.
PARATREND 7 NEOTREND MULTIPARAMETER/SENSOR WITH PARATREND 7 MULTIPARAMETER SENIOR AND SATELLITE MONITOR SYSTEM
K972314 · Diametrics Medical, Ltd. · Dec 1997
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
POINT-OF-CARE ARTERIAL BLOOD GAS MONITORING SYSTEM
K951094 · Optical Sensors, Inc. · Jan 1996
BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS
K901548 · Shiley, Inc. · Jan 1991
MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING
K891013 · Medtronic Vascular · Aug 1989