Cleared Special

K121017 - CAPNOGRAPHY PAD (92516)

K121017 is an FDA 510(k) clearance for CAPNOGRAPHY PAD (92516), manufactured by Spacelabs Healthcare. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Special 510(k) pathway after a 100-day FDA review.

K121017 · Spacelabs Healthcare · Anesthesiology device
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Jul 2012
Decision
100d
Days
Class 2
Risk

K121017 is an FDA 510(k) clearance for the CAPNOGRAPHY PAD (92516). Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Spacelabs Healthcare (Nederland, US). The FDA issued a Cleared decision on July 13, 2012 after a review of 100 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spacelabs Healthcare devices

FDA 510(k) Submission Details - K121017

510(k) Number K121017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2012
Decision Date July 13, 2012
Days to Decision 100 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
40d faster than avg
Panel avg: 140d · This submission: 100d
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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