510(k) · Cleared
Recalled · Class II · 2024F&P Airvo 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare · QAV High Flow/High Velocity Humidified Oxygen Delivery Device
Cleared on Jan 27, 2023 as substantially equivalent to DEN170001 (Vapotherm, Inc., 2018) and 1 other predicate after a 263-day review. Its family tree reaches back 9 generations to 1992. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 27, 2023
- Review
- 263 days
- Class
- Class II
- Product code
- QAV
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K913368 (1992). 22 ancestors in all, the oldest K902506 (1991). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 5 generations between
- 3 generations backK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
- 2 generations backK121975 Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013
- 1 generation backK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
- This deviceK221338 F&P Airvo 3Fisher & Paykel Healthcare · 2023
- Descendant · cites it directly · 1 of its ownK233643 F&P Airvo 3 NIV (PT311US)Fisher & Paykel Healthcare, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK242931 HFT750UMekics Co., Ltd. · 2025
Show all 9 generations
- Root · 9 generations backK913368 Models MR700/MR720/MR730 Dual Servo Resp Humid AccFisher & Paykel Electronics, Ltd. · 1992
- 8 generations backK953392 HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories)Fisher & Paykel Electronics, Ltd. · 1996
- 7 generations backK983112 Respiratory Humidifier, Model # MR850Fisher & Paykel Healthcare, Ltd. · 1998 · Recalled
- 6 generations backK020332 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2003 · Recalled
- 5 generations backK033710 MR850 Respiratory Humidifier, Model MR850JHUFisher & Paykel Healthcare, Ltd. · 2004
- 4 generations backK073706 Respiratory Humidifier, Model MR850Fisher & Paykel Healthcare, Ltd. · 2008
- 3 generations backK092846 Airvo Series HumidifiersFisher & Paykel Healthcare, Ltd. · 2010
- 2 generations backK121975 Airvo Humidifier Myairo HumidifierFisher & Paykel Healthcare, Ltd. · 2013
- 1 generation backK131895 Airvo 2 Humidifier, Myairvo 2 HumidifierFisher & Paykel Healthcare, Ltd. · 2013 · Recalled
- This deviceK221338 F&P Airvo 3Fisher & Paykel Healthcare · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K913368 | Models MR700/MR720/MR730 Dual Servo Resp Humid Acc | Fisher & Paykel Electronics, Ltd. | 1992 | — |
| −8 | K953392 | HC500 Servo-Controlled Heated Respiratory Humidifier (& Accessories) | Fisher & Paykel Electronics, Ltd. | 1996 | — |
| −7 | K983112 | Respiratory Humidifier, Model # MR850 | Fisher & Paykel Healthcare, Ltd. | 1998 | 5 |
| −6 | K020332 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2003 | 1 |
| −5 | K033710 | MR850 Respiratory Humidifier, Model MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −4 | K073706 | Respiratory Humidifier, Model MR850 | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −3 | K092846 | Airvo Series Humidifiers | Fisher & Paykel Healthcare, Ltd. | 2010 | — |
| −2 | K121975 | Airvo Humidifier Myairo Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | — |
| −1 | K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | Fisher & Paykel Healthcare, Ltd. | 2013 | 2 |
| 0 (this device) | K221338 | F&P Airvo 3 | Fisher & Paykel Healthcare | 2023 | — |
| +1 | K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | 2024 | — |
| +2 | K242931 | HFT750U | Mekics Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 2 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 K221318 HVT 2.0score 4.5 · 1 generation · no Class I recall
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN170001 | Precision Flow® HVNISummary page 4…Secondary Product Code BTT III. PREDICATE DEVICES • Primary Predicate Device FDA Clearance Number Device Name DEN170001 Precision Flow® HVNI • Secondary Predicate Device FDA Clearance Number… | 2018 |
| * | K131895 | Airvo 2 Humidifier, Myairvo 2 HumidifierSummary page 4…vice Name DEN170001 Precision Flow® HVNI • Secondary Predicate Device FDA Clearance Number Device Name K131895 AIRVO 2 Humidifier… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233643 | F&P Airvo 3 NIV (PT311US) | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2024 | Class II | Z-3262-2024 | Software change control | Due to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will deliver room air only. If this happens, a patient my experience oxygen desaturation that could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K233643 (Fisher & Paykel Healthcare, Ltd., 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate DEN170001.
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. 2023, 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?
The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the…
Read the full statement (153 words)
The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and sub-acute facilities. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals and sub-acute facilities.
The Airvo 3 provides high flow gases with simultaneous oxygen delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 is not intended to provide total ventilatory requirements and is not for use during field transport.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221338: F&P Airvo 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221338
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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