# K023068: Papillon Mask Set

- Pathway: 510(k) (Traditional)
- Applicant: Map Medizintechnik Fur Arzt Und Patient GmbH
- Decided: May 28, 2003 after 254 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K984428 (1999). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
2 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984428: Sullivan Autoset Nasal Cpap System, Resmed, Ltd. (1999) Summary page 1.

## Most influential descendants
- K082866: Revolutionfull Face Mask (2009), 2 descendants of its own
- K140580: Revolution Fullface Mask (2015), 0 descendants of its own
- K142554: Revolution Full Face Mask (2015), 0 descendants of its own

## Indications for use
The Papillon Mask Set is intended to be used with positive airway pressure devices such as CPAP (Continuous Positive Airway Pressure), operating at or above 4 cm H₂O for the treatment of adult obstructive sleep apnea. The mask is single patient reusable:

Source page: https://510kreport.com/device/K023068
Methodology: https://510kreport.com/methodology