# K070416: Neopeep Neonatal Resuscitation Circuit with Peep

- Pathway: 510(k) (Traditional)
- Applicant: Neoforce Group, Inc.
- Decided: May 29, 2007 after 106 days
- Product code: BYE (Attachment, Breathing, Positive End Expiratory Pressure)
- Device class: 2
- Regulation: 21 CFR 868.5965
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K892885 (1989). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 5 devices in its family (counting itself) has 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 1.
- K981415: 0-20 CM H20 Peep Valve, Cheen Houng Ent. Co., Ltd. (1998) Summary page 1.

## Most influential descendants
- K103833: Neopip Patient Circuit with Peep (2011), 0 descendants of its own
- K092029: Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310 (2010), 0 descendants of its own

## Indications for use
The NeoPEEP Neonatal Resuscitation Circuit with PEEP valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator. This valve is designed into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube attachment.

Source page: https://510kreport.com/device/K070416
Methodology: https://510kreport.com/methodology