Cleared Traditional

K172365 - Panoramic Oxygen Mask (POM)

K172365 is an FDA 510(k) clearance for Panoramic Oxygen Mask (POM), manufactured by Pom Medical, LLC. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K172365 · Pom Medical, LLC · Anesthesiology device
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Apr 2018
Decision
258d
Days
Class 2
Risk

K172365 is an FDA 510(k) clearance for the Panoramic Oxygen Mask (POM). Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Pom Medical, LLC (Simi Valley, US). The FDA issued a Cleared decision on April 19, 2018 after a review of 258 days - an extended review cycle.

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. 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 Pom Medical, LLC devices

FDA 510(k) Submission Details - K172365

510(k) Number K172365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2017
Decision Date April 19, 2018
Days to Decision 258 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 140d · This submission: 258d
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 Consultant

Pom Medical, LLC C/O Promedic, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 152
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