# K034026: RT 138 & RT 141 Dual-Heated Neonatal Breathing Circuits

- Pathway: 510(k) (Traditional)
- Applicant: Fisher & Paykel Healthcare, Ltd.
- Decided: Jan 12, 2005 after 380 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: 4 generations back to K913368 (1992). 8 ancestors in all.
12 later devices descend from it; 2 cite it directly.
1 of 21 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020332: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2003) Summary page 1.

## Most influential descendants
- K103767: Dual Heated Infant Vreathing Cirouits (2012), 10 descendants of its own
- 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

## Indications for use
The dual-heated breathing circuits are intended as conduits of breathing gas for ventilation of patients, and to maintain the temperature of humidified inspired gas. The RT236 is used for flow rates between 0.3 and 4 L/min, and the RT235 is for flow rates greater than 4 L/min, for infant patients.

Source page: https://510kreport.com/device/K034026
Methodology: https://510kreport.com/methodology