# K122610: Plaxtron Cpap System, Model CH-FFM-87XX/CH-FFM-88XX Series

- Pathway: 510(k) (Traditional)
- Applicant: Sen MU Technology Co., Ltd.
- Decided: Aug 5, 2013 after 343 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: 3 generations back to K801883 (1980). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013884: Boussignac C.P.a.P. Device, Vygon SA (2003) Summary page 1.
- K080256: Pulmodyne CHF Flow Generator System, Pulmodyne (2008) Summary page 1.

## Indications for use
The PLAXTRON CPAP System is to provide CPAP to spontaneously breathing adult (>30kg) patients in the hospital and pre-hospital (EMS) environment.

Source page: https://510kreport.com/device/K122610
Methodology: https://510kreport.com/methodology