Class Class II
F&P Optiflow Flow Diverter (K234053)
Description
F&P Optiflow Flow Diverter by Fisher &Paykel Healthcare , Ltd., an FDA 510(k) cleared anesthesiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK234053
Clearance Date2024-08-09
Clearance TypeTraditional
Product CodeCBP
Regulation Number868.5870
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K234053
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 Flow Diverter (K234053) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K173770 | OJR215 Pressure Relief Manifold | Fisher & Paykel Healthcare Limited | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K262268 | Optiflow Oxygen Kit (AA484J) | Fisher and Paykel Healthcare Limited | 2026 |
Trace the full predicate network for K234053
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.