Cleared Traditional

HVT 2.0 (K203357) - FDA 510(k) Clearance

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

K203357 · Vapotherm, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
282d
Days
Class 2
Risk

K203357 is an FDA 510(k) clearance for the HVT 2.0. 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 August 25, 2021 after a review of 282 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 K203357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2020
Decision Date August 25, 2021
Days to Decision 282 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
142d slower than avg
Panel avg: 140d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 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 K203357.
inspired™ VHB20 Heated Humidifier
K222351 · Vincent Healthcare Products Limited · Dec 2022
F&P 850 AirSpiral Adult NIV and NHF Circuit Kit
K212031 · Fisher &Paykel Healthcare , Ltd. · Apr 2022
Optiflow Oxygen Kit
K211096 · Fisher &Paykel Healthcare , Ltd. · Jan 2022
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