# K050918: Koo Americas Valve Peep, Model KM-809

- Pathway: 510(k) (Traditional)
- Applicant: Koo Americas, Inc.
- Decided: Jun 6, 2005 after 55 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have 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) Mercury Medical PEEP Valve: named in the summary without a submission number

## Indications for use
The Koo PEEP valve is intended as a single-patient use device to provide positive-end expiratory pressure or Continuous Positive Airway Pressure when used with masks and manual resuscitators. The device is adjustable from 0cm to 20cm H20 pressure.

Source page: https://510kreport.com/device/K050918
Methodology: https://510kreport.com/methodology