De Novo · Granted
GrantedPrecision Flow® HVNI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vapotherm, Inc. · QAV High Flow/High Velocity Humidified Oxygen Delivery Device
Granted on Apr 10, 2018 as a new device type through De Novo after a 462-day review. 4 later devices descend from it.
- Decided
- Apr 10, 2018
- Review
- 462 days
- Class
- Class II
- Product code
- QAV
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN170001 Precision Flow® HVNIVapotherm, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK221338 F&P Airvo 3Fisher & Paykel Healthcare · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK233643 F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK242931 HFT750UMekics Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK221318 HVT 2.0Vapotherm, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K221338F&P Airvo 3Fisher & Paykel Healthcare · 2023 · cites it directly2descendants
- K233643F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd. · 2024 · 2 generations on1descendant
- K242931HFT750UMekics Co., Ltd. · 2025 · 3 generations on0descendants
- K221318HVT 2.0Vapotherm, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170001 | Precision Flow® HVNI | Vapotherm, Inc. | 2018 | — |
| +1 | K221338 | F&P Airvo 3 | Fisher & Paykel Healthcare | 2023 | 1 |
| +2 | K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | 2024 | — |
| +3 | K242931 | HFT750U | Mekics Co., Ltd. | 2025 | — |
| +1 | K221318 | HVT 2.0 | Vapotherm, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 K221338 F&P Airvo 3score 8.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K221338 (Fisher & Paykel Healthcare, 2023) has gone furthest, with 2 descendants of its own.
How does its category compare?
All QAV devicesQAV High Flow/High Velocity Humidified Oxygen Delivery Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QAV
1in 2023
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
MAUDE reports naming product code QAV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 1 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Precision Flow® HVNI is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.…
Read the full statement (126 words)
Precision Flow® HVNI is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital and subacute institutions settings. It adds heat and moisture to a blended medical air/ oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula.
Precision Flow® HVNI provides high velocity nasal insufflation (HVNI) with simultaneous oxygen delivery to augment breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. Precision Flow® HVNI is not intended to provide total ventilatory requirements of the patient and not for use during field transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170001 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN170001: Precision Flow® HVNI.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN170001
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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