# K220703: F&P 950 Respiratory Humidifier

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare
- Decided: Jun 16, 2023 after 463 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: 11 generations back to K913368 (1992). 35 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110019: Respiratory Humidifer, Fisher & Paykel Healthcare, Ltd. (2012) Summary page 5.
- K122432: Adult Evaqua 2' Dual Heated Breathing Circuits, Fisher & Paykel Healthcare, Ltd. (2012) Summary page 5.
- K162553: AirSpiral Heated Breathing Tube, Fisher & Paykel Healthcare (2018) Summary page 5.
- K103767: Dual Heated Infant Vreathing Cirouits, Fisher & Paykel Healthcare, Ltd. (2012) Summary page 5.
- K212031: F&P 850 AirSpiral Adult NIV and NHF Circuit Kit, Fisher & Paykel Healthcare, Ltd. (2022). Cleared while this submission was under review Summary page 5.
- K020332: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2003) Summary page 5.

## Most influential descendants
- K233821: F&P Optiflow Oxygen Kit (AA451J) (2024), 0 descendants of its own

## Indications for use
F&P 950 Respiratory Humidifier The F&P 950 Respiratory Humidifier is intended to provide heat and humidity to respiratory gases delivered to patients. It is for use in a hospital or long-term care facility by a health professional. F&P 950 Breathing Circuit Kits: 950A80J, 950A81J, 950A82J, 950A60J, 950A61J, 950A40J, AA451SU The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to adult, adolescent and child patients, within the limits of its stated technical specifications. F&P 950 Breathing Circuit Kits: 950P81J, 950P40J The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant, child and adolescent patients, within the limits of its stated technical specifications. F&P 950 Breathing Circuit Kits: 950N80J, 950N81J, 950N61J, 950N40J The breathing set is an accessory to the F&P 950 Respiratory Humidifier. It is intended for delivery of heated humidified respiratory gases to neonatal, infant and child patients, within the limits of its stated technical specifications.

Source page: https://510kreport.com/device/K220703
Methodology: https://510kreport.com/methodology