Cleared Traditional

K161953 - ReDe Mask (FDA 510(k) Clearance)

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

K161953 · Tereopneuma · Anesthesiology device
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Feb 2017
Decision
214d
Days
Class 2
Risk

K161953 is an FDA 510(k) clearance for the ReDe Mask. Classified as Device Indicating An Exhalation Event (product code PRK), Class II - Special Controls.

Submitted by Tereopneuma (San Diego, US). The FDA issued a Cleared decision on February 17, 2017 after a review of 214 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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.

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Submission Details

510(k) Number K161953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2016
Decision Date February 17, 2017
Days to Decision 214 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
75d slower than avg
Panel avg: 139d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PRK Device Indicating An Exhalation Event
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
Definition To Provide Visual Indication Of Each Exhalation Event
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.