# K120920: Hsiner Cpap Silicone Nasal Mask Size XS/Petite  Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Hsiner Company
- Decided: Jul 16, 2012 after 111 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: 5 generations back to K945938 (1996). 34 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 36 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063268: Cpap/Vpap Masks, Models 1225, 1205 and 1235, Hsiner Co., Ltd. (2007) Summary page 1.
- K060105: Vpap Iii ST-a/Kidsta Mask System, Resmed, Ltd. (2006) Summary page 1.
- K102224: Pixi Pediatric Mask, Resmed, Ltd. (2010) Summary page 1.
- K102502: Golife Nasal Mask, Respironics, Inc. (2010) Summary page 1.

## Most influential descendants
- 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) (2024), 0 descendants of its own

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

Source page: https://510kreport.com/device/K120920
Methodology: https://510kreport.com/methodology