# K102618: Ventstar Heated, Infinity ID Breathing Circuit Heated

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical AG & Co. KG
- Decided: Dec 10, 2010 after 88 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: 6 generations back to K913368 (1992). 10 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073706: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2008) Summary page 2.
- K033710: MR850 Respiratory Humidifier, Model MR850JHU, Fisher & Paykel Healthcare, Ltd. (2004) Summary page 2.
- K020332: Respiratory Humidifier, Model MR850, Fisher & Paykel Healthcare, Ltd. (2003) Summary page 2.
- K983112: Respiratory Humidifier, Model # MR850, Fisher & Paykel Healthcare, Ltd. (1998) Summary page 2.
- K934140: MR290 Humidification Chamber Single Use, Fisher & Paykel Electronics, Ltd. (1994) Summary page 2.

## Most influential descendants
- K222822: VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) (2023), 1 descendant of its own
- K242769: VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) (2025), 0 descendants of its own

## Indications for use
VentStar Dual Heated / VentStar Heated Disposable inspiratory heated breathing circuit with humidifier chamber for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and adult patients with a body weight of at least 40 kg (88 Ibs). VentStar Heated (N)J/ VentStar Heated (N) basic Disposable inspiratory heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and neonatal patients with a body weight of uip to 5 kg (11 Ibs). Infinity ID Breathing Circuit Heated (N) Inspiratory heated breathing circuit for connection to a Fisher & Paykel MR8SO humidifier, for conveying moistened breathing gas between the humidifier and neonates with a body weight of up to 5 kg (11 lbs)lIntended for single-use only. Breathing circuit with integrated transponder. The transponder serves as a carrier of product-specific data for processing by Driger Infinity ID equipment. Infinity ID Breathing Circuit Dual Heated / Infinity ID Breathing Circuit Heated Heated breathing circuit for connection to a Fisher & Paykel MR850 humidifier, for conveying moistened breathing gas between the humidifier and adults with a body weight of at least 40 kg (88 Ibs). Intended for single-use only. Breathing circuit with integrated transponder. The transponder serves as a carrier of product-specific data for processing by Or~ger Infinity ID equipment.

Source page: https://510kreport.com/device/K102618
Methodology: https://510kreport.com/methodology