Cleared Traditional

K221318 - HVT 2.0

K221318 is an FDA 510(k) clearance for HVT 2.0, manufactured by Vapotherm, Inc.. The device is a Class 2 Anesthesiology device with product code QAV cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K221318 · Vapotherm, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
221d
Days
Class 2
Risk

K221318 is an FDA 510(k) clearance for the HVT 2.0. Classified as High Flow/high Velocity Humidified Oxygen Delivery Device (product code QAV), Class II - Special Controls.

Submitted by Vapotherm, Inc. (Exeter, US). The FDA issued a Cleared decision on December 13, 2022 after a review of 221 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5454 - 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

FDA 510(k) Submission Details - K221318

510(k) Number K221318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2022
Decision Date December 13, 2022
Days to Decision 221 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
81d slower than avg
Panel avg: 140d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QAV Device Classification - Class 2, Special Controls

Product Code QAV High Flow/high Velocity Humidified Oxygen Delivery Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5454
Definition Intended To Deliver High Flow And/or High Velocity Oxygen With Humidification.
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.