Class Class II
F&P Optiflow Air/Oxygen Flow Source (K243917)
Description
F&P Optiflow Air/Oxygen Flow Source by Fisher &Paykel Healthcare , Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243917
Clearance Date2025-07-14
Clearance TypeTraditional
Product CodeBZR
Regulation Number868.5330
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243917
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 Optiflow Air/Oxygen Flow Source (K243917) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K161718 | MaxBlend 2, MaxBlend Lite | Maxtec, LLC | 2016 |
| K131895 | AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER | Fisher & Paykel Healthcare, Ltd. | 2013 |
Trace the full predicate network for K243917
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.