# K981415: 0-20 CM H20 Peep Valve

- Pathway: 510(k) (Traditional)
- Applicant: Cheen Houng Ent. Co., Ltd.
- Decided: Jul 14, 1998 after 85 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Life Design PEEP FLO PEEP Valves: named in the summary without a submission number

## Most influential descendants
- K070416: Neopeep Neonatal Resuscitation Circuit with Peep (2007), 2 descendants of its own
- 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 Cheen Houng 0-20 Cm H20 PEEP Valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator.

Source page: https://510kreport.com/device/K981415
Methodology: https://510kreport.com/methodology