# K063268: Cpap/Vpap Masks, Models 1225, 1205 and 1235

- Pathway: 510(k) (Traditional)
- Applicant: Hsiner Co., Ltd.
- Decided: Feb 23, 2007 after 116 days
- Product code: BZD (Ventilator, Non-Continuous (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5905
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K833786 (1983). 8 ancestors in all.
4 later devices descend from it; 3 cite it directly.
1 of 13 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002465: Spectrum 2 Reusable Full Face Mask, Model 1004884 and 1004876, Respironics, Inc. (2000) Summary page 1.
- K961915: Spectrum Reusable Full Face Mask - Size Petite, Small, Medium, Large, Respironics, Inc. (1996) Summary page 1.
- K000705: Respironics Silhouette Nasal Mask, Models 1003224 and 1003223, Respironics, Inc. (2000) Summary page 1.
- K991648: Reusable Contour II Nasal Mask, Respironics, Inc. (1999) Summary page 1.

## Most influential descendants
- K120920: Hsiner Cpap Silicone Nasal Mask Size XS/Petite  Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula (2012), 1 descendant of its own
- 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
- K102120: Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202 (2011), 0 descendants of its own
- K072755: Galemed Cpap Mask (2007), 0 descendants of its own

## Recalls of this device
- Jun 18, 2018 · Class I · Z-2741-2018: A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of 

## Indications for use
The Hsiner CPAP/VPAP masks are intended to be use in a home, hospital or Institutional environments for patients who have been prescribed CPAP/VPAP therapy. This device is intended to be use under the specific direction of a physician.

Source page: https://510kreport.com/device/K063268
Methodology: https://510kreport.com/methodology