Cleared Traditional

K161250 - OC-FLEX Flexible IntraOral Cannula

K161250 is an FDA 510(k) clearance for OC-FLEX Flexible IntraOral Cannula, manufactured by Venture Therapeutics, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K161250 · Venture Therapeutics, Inc. · Anesthesiology device
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Mar 2017
Decision
318d
Days
Class 2
Risk

K161250 is an FDA 510(k) clearance for the OC-FLEX Flexible IntraOral Cannula. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Venture Therapeutics, Inc. (Columbus, US). The FDA issued a Cleared decision on March 17, 2017 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Venture Therapeutics, Inc. devices

FDA 510(k) Submission Details - K161250

510(k) Number K161250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2016
Decision Date March 17, 2017
Days to Decision 318 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 140d · This submission: 318d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 180
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K161250.
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CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
K150245 · GE Healthcare Finland Oy · Jul 2015