# K092029: Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical AG & Co. KG
- Decided: Aug 6, 2010 after 396 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K892885 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070416: Neopeep Neonatal Resuscitation Circuit with Peep, Neoforce Group, Inc. (2007) Summary page 2.

## Recalls of this device
- Sep 3, 2026 · Class I · Z-3252-2026: Potential cracks in the hose, which could lead to leakage or the hose falling off.

## Indications for use
The VentStar Resuscitaire CEU with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability. The valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The VentStar Resuscitaire CEU is a disposable breathing circuit for the transmission of breathing gases from a breathing gas source (Resuscitation Module) to the newborn patient in labor and delivery environments. It is suitable for newborn patients from birth to 1 month of age (maximum body weight of 10 kg (22 Ib)). It is intended exclusively for use in combination with the Resuscitaire Radiant Warmer.

Source page: https://510kreport.com/device/K092029
Methodology: https://510kreport.com/methodology