# K103767: Dual Heated Infant Vreathing Cirouits

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Apr 16, 2012 after 480 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: 5 generations back to K913368 (1992). 9 ancestors in all.
10 later devices descend from it; 6 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034026: RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits, Fisher & Paykel Healthcare, Ltd. (2005) Summary page 1.

## Most influential descendants
- K122432: Adult Evaqua 2' Dual Heated Breathing Circuits (2012), 6 descendants of its own
- K220703: F&P 950 Respiratory Humidifier (2023), 1 descendant of its own
- K222822: VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) (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

## Indications for use
The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of infant patients, and to maintain the temperature of humidified inspired gas. The RT265 is used for flow rates greater than 4 L/min, and the RT266 is for flow rates between 0.3 and 4 L/min.

Source page: https://510kreport.com/device/K103767
Methodology: https://510kreport.com/methodology