# K122432: Adult Evaqua 2' Dual Heated Breathing Circuits

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Dec 6, 2012 after 118 days
- Product code: BZE (Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer)
- Device class: 2
- Regulation: 21 CFR 868.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K913368 (1992). 10 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103767: Dual Heated Infant Vreathing Cirouits, Fisher & Paykel Healthcare, Ltd. (2012) Summary page 1.

## Most influential descendants
- K220703: F&P 950 Respiratory Humidifier (2023), 1 descendant of its own
- K152029: Hamilton-H900, Hamilton-BC8022, Hamilton-BC4022, Hamilton-BC8010, Hamilton-BC4010 (2016), 1 descendant of its own
- K252066: inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009);  inspired™ Auto-feed Humidification Chamber  (VHC10); inspired™ Auto-feed Humidification Chamber  (VHC20) (2026), 0 descendants of its own
- K233821: F&P Optiflow Oxygen Kit (AA451J) (2024), 0 descendants of its own
- K163283: Hamilton-H900, Hamilton-BC8010, Hamilton-BC4010 (2017), 0 descendants of its own

## Indications for use
The RT380 and RT385 'Adult Evaqua 2' dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of adult patients, and to maintain the temperature of humidified, inspired gas.

Source page: https://510kreport.com/device/K122432
Methodology: https://510kreport.com/methodology