# K160540: Flexicare Neonatal Heated Wire Breathing System

- Pathway: 510(k) (Traditional)
- Applicant: Flexicare Medical Limited.
- Decided: Jun 23, 2016 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: 5 generations back to K913368 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have 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 5.
- K934140: MR290 Humidification Chamber Single Use, Fisher & Paykel Electronics, Ltd. (1994) Summary page 5.

## Indications for use
Flexicare Neonatal Heated Wire Breathing Systems are intended for use to connect a patient’s airway to a Ventilator and Humidification Chamber as part of a complete system to provide warmed and humidified inspired respiratory gases to ventilated patients and those receiving respiratory support. Intended for Neonatal patients within a hospital environment. Compatible with Fisher & Paykel MR850 Respiratory Gas Humidifier. Available in Neonatal (038-33-201U) size. For flow rates >4L/min. Humidification Chambers are intended for use to hold water required to humidify the air being delivered to patients. Intended for any patient requiring active humidification within a hospital environment.

Source page: https://510kreport.com/device/K160540
Methodology: https://510kreport.com/methodology