# K253166: F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)

- Pathway: 510(k) (Traditional)
- Applicant: BMC Medical Co., Ltd.
- Decided: Apr 29, 2026 after 215 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: 9 generations back to K945938 (1996). 38 ancestors in all.
No later device cites it as a predicate yet.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210844: DreamWear Silicone Pillows Mask, Respironics, Inc. (2021) Summary page 5.
- K234134: AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System, Resmed Pty Ltd (Registration Number: 3004604967) (2024) Summary page 5.

## Indications for use
The Nasal Pillows Interface (P6S) is intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. The Nasal Pillows Interface (P6S) is: - to be used by patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment. The Full Face Mask (F6S) is intended to provide an interface for patients who have been prescribed CPAP or bi-level therapy. The Full Face Mask (F6S) is: - to be used by patients (> 66 lbs. / 30 kg) for whom positive airway pressure therapy has been prescribed. - intended for single-patient re-use in the home environment.

Source page: https://510kreport.com/device/K253166
Methodology: https://510kreport.com/methodology