Cleared Traditional

K193411 - O2asis Personal Oxygen Humidifier

K193411 is an FDA 510(k) clearance for O2asis Personal Oxygen Humidifier, manufactured by Perma Pure, LLC. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K193411 · Perma Pure, LLC · Anesthesiology device
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Nov 2020
Decision
339d
Days
Class 2
Risk

K193411 is an FDA 510(k) clearance for the O2asis Personal Oxygen Humidifier. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Perma Pure, LLC (Lakewood, US). The FDA issued a Cleared decision on November 12, 2020 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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. Elevated predicate reliance profile. 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 Perma Pure, LLC devices

FDA 510(k) Submission Details - K193411

510(k) Number K193411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2019
Decision Date November 12, 2020
Days to Decision 339 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
199d slower than avg
Panel avg: 140d · This submission: 339d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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

Perma Pure, 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 - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 153
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K193411.
Optiflow Oxygen Kit
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K191818 · Fisher &Paykel Healthcare , Ltd. · Mar 2020
Palladium High Flow Therapy System
K191010 · Vapotherm, Inc. · Oct 2019
AirSpiral Heated Breathing Tube
K162553 · Fisher & Paykel Healthcare · Dec 2018