Cleared Special

K010795 - CAPNOPROBE SL, MODEL 2000

K010795 is an FDA 510(k) clearance for CAPNOPROBE SL, manufactured by Optical Sensors, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Special 510(k) pathway after a 26-day FDA review.

K010795 · Optical Sensors, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
26d
Days
Class 2
Risk

K010795 is an FDA 510(k) clearance for the CAPNOPROBE SL, MODEL 2000. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Optical Sensors, Inc. (Stoughton, US). The FDA issued a Cleared decision on April 11, 2001 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Optical Sensors, Inc. devices

FDA 510(k) Submission Details - K010795

510(k) Number K010795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2001
Decision Date April 11, 2001
Days to Decision 26 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 140d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

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