# K222197: F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Apr 6, 2023 after 258 days
- Product code: BTT (Humidifier, Respiratory Gas, (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913368 (1992). 22 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162553: AirSpiral Heated Breathing Tube, Fisher & Paykel Healthcare (2018) Summary page 5.

## Most influential descendants
- K250312: Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small (2025), 0 descendants of its own
- K241778: Hudson RCI Comfort Flo® CubCannula™ (2024), 0 descendants of its own
- K240163: Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula (2024), 0 descendants of its own

## Indications for use
F&P Optiflow Junior 2: The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients. This product is designed for use in hospital environments and must be prescribed by a physician. The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes: *Neonates, birth up to 1 month of age * Infants, 1 month up to 2 years of age * Children, 2 years up to 12 years of age F&P Optiflow Junior 2+ The Fisher & Paykel Healthcare Optiflow Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NHF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients. This product is designed for use in hospital environments and must be prescribed by a physician. The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes: * Infants, 1 month up to 2 years of age * Children, 2 years up to 12 years of age F&P Optiflow Junior 2 HM Cannula The Fisher & Paykel Healthcare Optiflow Junior 2 nasal cannula is a single use nasal cannula intended for use with a nasal high flow therapy (NIIF) system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients. This product is designed for use in long term care environments and must be prescribed by a physician. The intended pediatric subpopulations targeted for use of the F&P Optiflow Junior 2 Nasal Cannula range includes: * Infants, 1 month up to 2 years of age * Children, 2 years up to 12 years of age F&P Optiflow Junior 2+ HM Cannula The Fisher & Paykel Healthcare Optiflownm Junior 2+ nasal cannula is a single use nasal cannula intended for use with a nasal high flow (NHF) therapy system to deliver heated and humidified nasal high flow therapy to spontaneously breathing patients. This product is designed for use in long term care environments and must be prescribed by a physician. The intended pediatric subpopulation targeted for use on the F&P Optiflow Junior 2+ Nasal Cannula includes: * Infants, 1 month up to 2 years of age * Children, 2 years up to 12 years of age

Source page: https://510kreport.com/device/K222197
Methodology: https://510kreport.com/methodology