Cleared Traditional

K142402 - BigEasy Non-Rebreathing Valve

K142402 is an FDA 510(k) clearance for BigEasy Non-Rebreathing Valve, manufactured by 12th Man Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 208-day FDA review.

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

FDA 510(k) Submission Details - K142402

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
68d slower than avg
Panel avg: 140d · This submission: 208d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - CBP Valve, Non-rebreathing

All 36
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