# K234053: F&P Optiflow Flow Diverter

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Aug 9, 2024 after 231 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K173770 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173770: OJR215 Pressure Relief Manifold, Fisher & Paykel Healthcare Limited (2019) Summary page 5.

## Indications for use
This product is intended for use as an in-line pressure relief device, designed to limit the system pressure within the limits of its stated technical specifications. This product is indicated for patients in a hospital for use by appropriately qualified healthcare professionals.

Source page: https://510kreport.com/device/K234053
Methodology: https://510kreport.com/methodology