510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221318Substantially Equivalent

Hvt 2.0

Vapotherm Inc., Exeter NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221318 is the FDA 510(k) clearance record for HVT 2.0, a class II device, cleared for Vapotherm, Inc. on under FDA product code QAV (High Flow/High Velocity Humidified Oxygen Delivery Device). FDA's definition for product code QAV reads: "Intended to deliver high flow and/or high velocity oxygen with humidification". FDA records list 13 510(k) clearances for Vapotherm, Inc., from to . As of , FDA records show no recalls naming K221318.

Clearance record

Decision date
Received
(221 days to decision)
Product code
QAV High Flow/High Velocity Humidified Oxygen Delivery Device
Regulation
21 CFR 868.5454
Device class
Class II
Review panel
Anesthesiology
Applicant
Vapotherm, Inc. 100 Domain Dr., Exeter NH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QAV

Trailing 12 months

FDA records hold no clearances under product code QAV in the trailing twelve months.

FDA records show no clearances under product code QAV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QAV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260