Cleared Special

K143469 - SOFTECH Plus ETCO2 Cannula

K143469 is an FDA 510(k) clearance for SOFTECH Plus ETCO2 Cannula, manufactured by Teleflexmedical, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Special 510(k) pathway after a 69-day FDA review.

K143469 · Teleflexmedical, Inc. · Anesthesiology device
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Feb 2015
Decision
69d
Days
Class 2
Risk

K143469 is an FDA 510(k) clearance for the SOFTECH Plus ETCO2 Cannula. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on February 12, 2015 after a review of 69 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 Teleflexmedical, Inc. devices

FDA 510(k) Submission Details - K143469

510(k) Number K143469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2014
Decision Date February 12, 2015
Days to Decision 69 days
Submission Type Special
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
71d faster than avg
Panel avg: 140d · This submission: 69d
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

All 179
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