# K162553: AirSpiral Heated Breathing Tube

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare
- Decided: Dec 20, 2018 after 828 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: 9 generations back to K913368 (1992). 21 ancestors in all.
15 later devices descend from it; 8 cite 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)
- K131895: Airvo 2 Humidifier, Myairvo 2 Humidifier, Fisher & Paykel Healthcare, Ltd. (2013) Summary page 4.

## Most influential descendants
- K222197: F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range (2023), 3 descendants of its own
- K212031: F&P 850 AirSpiral Adult NIV and NHF Circuit Kit (2022), 2 descendants of its own
- K211096: Optiflow Oxygen Kit (2022), 2 descendants of its own
- K201723: F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling (2021), 2 descendants of its own
- K234058: F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility  (AA041J) (2024), 1 descendant of its own

## Indications for use
The 900PT561 heated breathing tube is for delivery of humidified respiratory gases. For use with AIRVO™ and AIRVO™ 2 Series humidifiers in hospitals and long-term care facilities. For use at flows from 2 to 60 L/min depending on the patient interface. The 900PT560 and 900PT560E heated breathing tube is for delivery of humidified respiratory gases. For use with myAIRVO™ and myAIRVO™ 2 Series humidifiers in homes and long-term care facilities. For use at flows from 2 to 60 L/min depending on the patient interface.

Source page: https://510kreport.com/device/K162553
Methodology: https://510kreport.com/methodology