Cleared Traditional

Palladium High Flow Therapy System (K191010) - FDA 510(k) Clearance

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

K191010 · Vapotherm, Inc. · Anesthesiology device
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Oct 2019
Decision
177d
Days
Class 2
Risk

K191010 is an FDA 510(k) clearance for the Palladium High Flow Therapy System. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Vapotherm, Inc. (Exeter, US). The FDA issued a Cleared decision on October 10, 2019 after a review of 177 days - an extended review cycle.

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. 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 Vapotherm, Inc. devices

Submission Details

510(k) Number K191010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2019
Decision Date October 10, 2019
Days to Decision 177 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 140d · This submission: 177d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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

Third Party Review Group, LLC
Dave Yungvirt

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 50
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K191010.
F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling
K201723 · Fisher &Paykel Healthcare , Ltd. · Mar 2021
O2asis Personal Oxygen Humidifier
K193411 · Perma Pure, LLC · Nov 2020
F&P Optiflow 3S Nasal Cannula (Small, Medium, Large)
K191818 · Fisher &Paykel Healthcare , Ltd. · Mar 2020
AirSpiral Heated Breathing Tube
K162553 · Fisher & Paykel Healthcare · Dec 2018
TNI softFlow 50
K180474 · Tni Medical AG · Oct 2018
H2 HEATED HUMIDIFIER
K030090 · Respironics, Inc. · Jan 2003