Class Class II
F&P Airvo 3 (K221338)
Description
F&P Airvo 3 by Fisher & Paykel Health Care, an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK221338
Clearance Date2023-01-27
Clearance TypeTraditional
Product CodeQAV
Regulation Number868.5454
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221338
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. F&P Airvo 3 (K221338) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare | 2018 |
| K131895 | AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER | Fisher & Paykel Healthcare, Ltd. | 2013 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233643 | F&P Airvo 3 NIV (PT311US) | Fisher & Paykel Healthcare, Ltd. | 2024 |
| K223863 | BONHAWA Respiratory Humidifier | Telesair, Inc. | 2023 |
Trace the full predicate network for K221338
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.