# K211096: Optiflow Oxygen Kit

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jan 28, 2022 after 290 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.
2 later devices descend from it; 2 cite it directly.
0 of 25 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
- K262268: Optiflow Oxygen Kit (AA484J) (2026), 0 descendants of its own
- K233821: F&P Optiflow Oxygen Kit (AA451J) (2024), 0 descendants of its own

## Indications for use
This product delivers respiratory gases to adult patients. It is intended for use with an MR810 humidifier at flows from 5 to 70 L/min. This product can be used on multiple patients when used with a hydrophobic filter between the product and the patient interface for a maximum of 24 hours after set-up. This product is indicated for the delivery of Nasal High Flow (NHF) by appropriately qualified healthcare professionals under the direction of a physician anesthesiologist in a medical procedure or surgical room. Qualitative carbon dioxide sampling can be used at nasal cannula flow rates from 5 to 50 L/min. This product can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation in operating rooms under the direction of a physician anesthesiologist. This product is not intended for apneic ventilation.

Source page: https://510kreport.com/device/K211096
Methodology: https://510kreport.com/methodology