Cleared Traditional

TAP PAP NASAL PILLOW MASK (K122350) - FDA 510(k) Clearance

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

K122350 · Airway Management, Inc. · Anesthesiology device
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Nov 2012
Decision
90d
Days
Class 2
Risk

K122350 is an FDA 510(k) clearance for the TAP PAP NASAL PILLOW MASK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Airway Management, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on November 1, 2012 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Airway Management, Inc. devices

Submission Details

510(k) Number K122350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2012
Decision Date November 01, 2012
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 208
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K122350.
SWIFT FX NANO
K123789 · Resmed, Ltd. · Mar 2013
KANGAROO NASAL MASK
K122847 · Respironics, Inc. · Mar 2013
QUATTRO AIR
K123979 · Resmed, Ltd. · Feb 2013
GEO
K121705 · Resmed, Ltd. · Oct 2012
REMSTAR SE
K122769 · Respironics, Inc. · Oct 2012
SIMPLE T NASAL MASK
K121631 · Respironics, Inc. · Oct 2012