# K013884: Boussignac C.P.a.P. Device

- Pathway: 510(k) (Traditional)
- Applicant: Vygon SA
- Decided: Jan 21, 2003 after 424 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 K801883 (1980). 6 ancestors in all.
4 later devices descend from it; 4 cite it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904874: Adjustable Peep Valve, Vital Signs, Inc. (1991) Summary page 1.
- K831503: Downs Adjustable Flow Generator, Vital Signs, Inc. (1983) Summary page 1.
- K982283: Whisperflow Oxygen Flow Generator - Adjustable Model WF 8500 Whisperflow Oxygen Flow Generator - Fixed Model WF 8530 WH, Caradyne, Ltd. (1999) Summary page 1.

## Most influential descendants
- K123957: Pneupac Parapac Plus (2013), 0 descendants of its own
- K122610: Plaxtron Cpap System, Model CH-FFM-87XX/CH-FFM-88XX Series (2013), 0 descendants of its own
- K112546: O_Two Cpap System (2011), 0 descendants of its own
- K090710: Mercury Cpap (2009), 0 descendants of its own

## Indications for use
The Boussignac C.P.A.P. Device is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.

Source page: https://510kreport.com/device/K013884
Methodology: https://510kreport.com/methodology