# K212031: F&P 850 AirSpiral Adult NIV and NHF Circuit Kit

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Apr 22, 2022 after 297 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). 30 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 33 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 4.
- K982454: Bipap Vision Ventilatory Support, Respironics, Inc. (1998) Summary page 4.

## Most influential descendants
- K220703: F&P 950 Respiratory Humidifier (2023), 1 descendant of its own
- K233821: F&P Optiflow Oxygen Kit (AA451J) (2024), 0 descendants of its own

## Indications for use
For the delivery of heated, humidified breathing gases to spontaneously breathing adult patients. This breathing set is suitable for use with Fisher & Paykel Healthcare MR850 Humidifiers in hospital and long-term care environments.

Source page: https://510kreport.com/device/K212031
Methodology: https://510kreport.com/methodology