510(k) Report

510(k) · Cleared

Cleared

HVT 2.0

K221318510(k) TraditionalCleared Dec 13, 2022221-day reviewClass II21 CFR 868.5454

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vapotherm, Inc. · QAV High Flow/High Velocity Humidified Oxygen Delivery Device

Cleared on Dec 13, 2022 as substantially equivalent to DEN170001 (Vapotherm, Inc., 2018) after a 221-day review. Its family tree reaches back 1 generation to 2018.

Decided
Dec 13, 2022
Review
221 days
Class
Class II
Product code
QAV
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to DEN170001 (2018). No later device cites it as a predicate yet.

Reference device: K203357 · HVT 2.0 · Vapotherm, Inc. · 2021DEN170001 · Precision Flow® HVNI · Vapotherm, Inc. · 201820162018202020222024
DEN170001 · Precision Flow® HVNI · Vapotherm, Inc. · 20180
  1. Root · 1 generation backDEN170001 Precision Flow® HVNIVapotherm, Inc. · 2018
  2. This deviceK221318 HVT 2.0Vapotherm, Inc. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1DEN170001Precision Flow® HVNIVapotherm, Inc.2018—
0 (this device)K221318HVT 2.0Vapotherm, Inc.2022—
FIG. 1 — Lineage of K221318, 2018–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in QAV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new QAV device

  1. #1 K221338 F&P Airvo 3score 8.1 · 9 generations · no Class I recall
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*DEN170001Precision Flow® HVNI
Summary page 4
…fied Oxygen Delivery Device Classification: 21 CFR 868.5454, Class II Product Code: QAV Predicate Device: DEN170001 Vapotherm Precision Flow HVNI Reference Device: K203357 Vapotherm HVT 2.0 Device Description: The HVT 2.0 System…
Vapotherm, Inc.2018—
†K203357HVT 2.0Vapotherm, Inc.2021—

Also cleared against DEN170001: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate DEN170001.

How does its category compare?

All QAV devices

QAV High Flow/High Velocity Humidified Oxygen Delivery Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · QAV

1in 2023

2018: 12022: 12023: 1
2007high 1 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QAV

Too few QAV 510(k)s in any year since 2007 to give a median.

Recalls per year · QAV

No recall names QAV since 2007.

Adverse event reports per year · QAV

10in 2025

2020: 12021: 12022: 62023: 32024: 72025: 10
2007high 10 (2025) · low 0 (2007)2025

MAUDE reports naming product code QAV, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20181—00
20190—00
20200—01
20210—01
20221—06
20231—03
20240—07
20250—010
20260—0—

What is it indicated for?

The HVT 2.0 system provides high velocity nasal insufflation (HVNI) with simultaneous warmed and humidified respiratory gas delivery to augment breathing of spontaneously breathing adult and pediatric patients (5 kg and up) suffering from respiratory distress and/or hypoxemia in the hospital setting, via a small bore nasal cannula. HVT 2.0 is not intended to provide total ventilatory requirements of the patient and not for use during field transport. The flow rates may be from 5 to 45 liters per minute (BTPS).

Indications for use as stated in the FDA summary.

Also cleared against DEN170001

1 other device cites the same predicate.

  • K221338F&P Airvo 3Fisher & Paykel Healthcare · 20231 recall

More from Vapotherm, Inc.

13 FDA decisions under this applicant name. See the company

  • K254078HVT 2.0Vapotherm, Inc. · 2026
  • K220869Vapotherm Aerosol Adapter AAA-2Vapotherm, Inc. · 2022
  • K203357HVT 2.0Vapotherm, Inc. · 2021
  • K191010Palladium High Flow Therapy SystemVapotherm, Inc. · 2019
  • DEN170001Precision Flow® HVNIVapotherm, Inc. · 2018

Recent decisions in QAV

The QAV category page

  • K221338F&P Airvo 3Fisher & Paykel Healthcare · 20231 recall
  • DEN170001Precision Flow® HVNIVapotherm, Inc. · 2018

https://510kreport.com/device/K221318 · printed Nov 6, 2026

Cite this page

510(k) Report. “K221318: HVT 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221318

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026