# K242769: VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)

- Pathway: 510(k) (Traditional)
- Applicant: Draegerwerk AG & CO Kgaa
- Decided: Apr 4, 2025 after 203 days
- Product code: BTL (Ventilator, Emergency, Powered (Resuscitator))
- Device class: 2
- Regulation: 21 CFR 868.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K913368 (1992). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892885: Resubmitted RD1000 Neopuff Infant Resuscitator, Fisher & Paykel Electronics, Ltd. (1989) Summary page 5.
- K222822: VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608), Draegerwerk AG & CO Kgaa (2023) Summary page 5.

## Indications for use
VentStar Resus heated (N) (MP17030): VentStar Resus heated (N) with manual PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source (resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient. The product allows short-term ventilation with humidified breathing gas and additional PEEP. It can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port. The product is suitable for patients with a maximum body weight of 10 kg (22 lb). VentStar Autobreath heated (N) (MP17031): VentStar AutoBreath heated (N) with automatic PEEP valve is a disposable breathing circuit for conveying breathing gas from a breathing gas source resuscitation module) via the Fisher & Paykel MR850 humidifier to a patient. The product allows automatic short-term ventilation with humidified breathing gas and additional PEEP. The valve is controlled via the AutoBreath function of the resuscitation module. The product can be connected to a breathing mask, a laryngeal mask, or an endotracheal tube via the patient port. The product is suitable for patients with a maximum body weight of 10 kg (22 lb).

Source page: https://510kreport.com/device/K242769
Methodology: https://510kreport.com/methodology