# K173770: OJR215 Pressure Relief Manifold

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare Limited
- Decided: Apr 5, 2019 after 480 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K234053: F&P Optiflow Flow Diverter (2024), 0 descendants of its own

## Indications for use
The OJR215 Pressure Relief Manifold is designed to protect neonates, infants and children from excessive inspiratory pressure in the event of a downstream occlusion occurring in continuous flow breathing gas delivery systems via nasal cannula. The device is intended for use with flow rates greater than 0.5 L/min up to, and including, 36 L/min. The OJR215 is fitted upstream of the patient. The OJR215 is single use only and is prescription only. The OJR215 Pressure Relief Manifold is designed to protect neonates, infants and children from excessive inspiratory pressure in the event of a downstream occlusion occurring in continuous flow breathing gas delivery systems via nasal cannula. The device is intended for use with flow rates greater than 0.5 L/min up to, and including, 36 L/min. The OJR215 is fitted upstream of the patient. The OJR215 is single use only and is prescription only.

Source page: https://510kreport.com/device/K173770
Methodology: https://510kreport.com/methodology