Class Class II
F&P Solo Mask Range (K223696)
Description
F&P Solo Mask Range by Fisher &Paykel Healthcare , Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223696
Clearance Date2023-05-17
Clearance TypeTraditional
Product CodeBZD
Regulation Number868.5905
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223696
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 Solo Mask Range (K223696) cites 2 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, W... | Fisher & Paykel Healthcare, Ltd. | 2020 |
| K161412 | F&P Brevida™ Nasal Pillows Mask | Fisher & Paykel Healthcare, Ltd. | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K233829 | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro ... | Fisher and Paykel Healthcare Limited | 2024 |
Trace the full predicate network for K223696
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.