Cleared Traditional

K142402 - BigEasy Non-Rebreathing Valve (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K142402 · 12th Man Technologies, Inc. · Anesthesiology device
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Mar 2015
Decision
208d
Days
Class 2
Risk

K142402 is an FDA 510(k) clearance for the BigEasy Non-Rebreathing Valve. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by 12th Man Technologies, Inc. (Garden Grove, US). The FDA issued a Cleared decision on March 23, 2015 after a review of 208 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 12th Man Technologies, Inc. devices

Submission Details

510(k) Number K142402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2014
Decision Date March 23, 2015
Days to Decision 208 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
69d slower than avg
Panel avg: 139d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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.