# K243225: Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)

- Pathway: 510(k) (Special)
- Applicant: Genadyne Biotechnologies, Inc.
- Decided: Dec 31, 2024 after 84 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: 6 generations back to K945938 (1996). 35 ancestors in all.
No later device cites it as a predicate yet.
1 of 36 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120920: Hsiner Cpap Silicone Nasal Mask Size XS/Petite  Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula, Hsiner Company (2012) Summary page 5.

## Indications for use
The Nasal Pillow Mask is intended for patients (> 30 kg) who have been prescribed CPAP/VPAP therapy in home, hospital, or institutional environments. This device is intended to be use under the direction of a physician.

Source page: https://510kreport.com/device/K243225
Methodology: https://510kreport.com/methodology