Optiflow+ Nasal Cannula – Small (OPT942); Optiflow+ Nasal Cannula – Medium (OPT944); Optiflow+ Nasal Cannula – Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) (K251611)
Description
Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) by Fisher &Paykel Healthcare , Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251611
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. Optiflow+ Nasal Cannula – Small (OPT942); Optiflow+ Nasal Cannula – Medium (OPT944); Optiflow+ Nasal Cannula – Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) (K251611) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223684 | F&P 820 Humidification System | Fisher & Paykel Healthcare, Ltd. | 2023 |
| K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | 2023 |
| K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare | 2018 |
Trace the full predicate network for K251611
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.