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

High Flow/High Velocity Humidified Oxygen Delivery Device

21 CFR 868.5454 / Anesthesiology
FDA source (opens on fda.gov)

QAV is the FDA product code for High Flow/High Velocity Humidified Oxygen Delivery Device, a class II device type, regulated under 21 CFR 868.5454. FDA's definition for this code reads: "Intended to deliver high flow and/or high velocity oxygen with humidification". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QAV
Device name
High Flow/High Velocity Humidified Oxygen Delivery Device
FDA definition
Intended to deliver high flow and/or high velocity oxygen with humidification.
Regulation
21 CFR 868.5454
Device class
Class II
Review panel
Anesthesiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code QAV

By decision year
3 clearances under product code QAV with a decision year between 2018 and 2023, 2018 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QAV by decision year
YearClearances
20181
20221
20231

Applicants with the most clearances

Product code QAV
Applicants holding the most 510(k) clearances under product code QAV
ApplicantClearances
Vapotherm Inc.2
Fisher & Paykel Healthcare, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code