# K103833: Neopip Patient Circuit with Peep

- Pathway: 510(k) (Traditional)
- Applicant: Neoforce Group, Inc.
- Decided: Apr 20, 2011 after 111 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: 2 generations back to K892885 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have 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 1.
- (no number) Fisher & Paykel NEOPUFF Infant Resuscitator patient circuit with PEEP: named in the summary without a submission number
- (no number) Marshall Products NeoPEEP NeoNatal Resuscitation Circuit with PEEP: named in the summary without a submission number

## Indications for use
The NeoPIPTM Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a I-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit I-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients < 10Kg.

Source page: https://510kreport.com/device/K103833
Methodology: https://510kreport.com/methodology