510(k) · Cleared
ClearedHsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hsiner Company · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Jul 16, 2012 as substantially equivalent to K063268 (Hsiner Co., Ltd., 2007) and 3 other predicates after a 111-day review. Its family tree reaches back 5 generations to 1996. 1 of the 36 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jul 16, 2012
- Review
- 111 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K945938 (1996). 34 ancestors in all, the oldest K792018 (1979). 1 later device descends from it, 1 citing it directly. 1 of the 36 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK945938 Respironics Monarch Mini MaskRespironics, Inc. · 1996
- 4 generations backK992336 Monarch II Mini MaskRespironics, Inc. · 1999
- 3 generations backK053352 Comfortlite Nasal MaskRespironics, Inc. · 2006
- 2 generations backK090935 Minime Pediatric MaskSleepnet Corporation · 2009
- 1 generation backK102224 Pixi Pediatric MaskResmed, Ltd. · 2010
- This deviceK120920 Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow…Hsiner Company · 2012
- Descendant · cites it directly · 0 of its ownK243225 Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask -…Genadyne Biotechnologies, Inc. · 2024
Class I recalls in this family
- K063268 Cpap/Vpap Masks, Models 1225, 1205 and 1235direct predicate · 2007
Most influential descendants
Showing 1 of 1 · See all- K243225Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes…Genadyne Biotechnologies, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945938 | Respironics Monarch Mini Mask | Respironics, Inc. | 1996 | — |
| −4 | K992336 | Monarch II Mini Mask | Respironics, Inc. | 1999 | — |
| −3 | K053352 | Comfortlite Nasal Mask | Respironics, Inc. | 2006 | — |
| −2 | K090935 | Minime Pediatric Mask | Sleepnet Corporation | 2009 | — |
| −1 | K102224 | Pixi Pediatric Mask | Resmed, Ltd. | 2010 | — |
| 0 (this device) | K120920 | Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner… | Hsiner Company | 2012 | — |
| +1 | K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium… | Genadyne Biotechnologies, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 1 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZD device
- #1 K250624 myAirscore 15.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K063268 | Cpap/Vpap Masks, Models 1225, 1205 and 1235Summary page 1…PAP Masks (K K(063268) in addition to the following predicate devices; I1. Hsiner Pediatric CPAP Silicone Nasal Mask to the Hsiner CPAP/VPAP Nasal Masks (K063268)and ResMed's Mirage Kidsta Mask (K060105) and ResMeds PixiTM Pediatric Mask (K 102224), 2. Hsiner Nasal Pillow Ma… | 2007 |
| * | K060105 | Vpap Iii ST-a/Kidsta Mask SystemSummary page 1…following predicate devices; I1. Hsiner Pediatric CPAP Silicone Nasal Mask to the Hsiner CPAP/VPAP Nasal Masks (K063268)and ResMed's Mirage Kidsta Mask (K060105) and ResMeds PixiTM Pediatric Mask (K 102224), 2. Hsiner Nasal Pillow Mask to Repironics' GoLife Nasal Mask (K 10… | 2006 |
| * | K102224 | Pixi Pediatric MaskSummary page 1…ic CPAP Silicone Nasal Mask to the Hsiner CPAP/VPAP Nasal Masks (K063268)and ResMed's Mirage Kidsta Mask (K060105) and ResMeds PixiTM Pediatric Mask (K 102224), 2. Hsiner Nasal Pillow Mask to Repironics' GoLife Nasal Mask (K 102502). 13.5. Comparison to Predicate Devices There are… | 2010 |
| * | K102502 | Golife Nasal MaskSummary page 1…268)and ResMed's Mirage Kidsta Mask (K060105) and ResMeds PixiTM Pediatric Mask (K 102224), 2. Hsiner Nasal Pillow Mask to Repironics' GoLife Nasal Mask (K 102502). 13.5. Comparison to Predicate Devices There are no technological differences between these devices. 13.5.1. Design,… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243225 | Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes… | 2024 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K063268Cpap/Vpap Masks, Models 1225, 1205 and 1235Hsiner Co., Ltd. · 2007 · Direct predicate · ◆ in the 2007 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- 3 of the 34 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K243225 (Genadyne Biotechnologies, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K063268.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · BZD
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BZD
189in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZD
8in 2023
Class I (13 since 2007) Class II/III not classified
Adverse event reports per year · BZD
60,279in 2025
MAUDE reports naming product code BZD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 21 | 83 | 29 | 65 |
| 2008 | 17 | 108 | 2 | 67 |
| 2009 | 23 | 90 | 1 | 147 |
| 2010 | 12 | 122 | 0 | 143 |
| 2011 | 23 | 125 | 1 | 189 |
| 2012 | 21 | 133 | 0 | 139 |
| 2013 | 23 | 127 | 0 | 82 |
| 2014 | 14 | 172 | 0 | 86 |
| 2015 | 11 | 224 | 0 | 114 |
| 2016 | 12 | 217 | 0 | 118 |
| 2017 | 5 | 221 | 0 | 148 |
| 2018 | 5 | 280 | 0 | 101 |
| 2019 | 6 | 231 | 4 (4) | 188 |
| 2020 | 6 | 137 | 0 | 126 |
| 2021 | 6 | 192 | 0 | 6,066 |
| 2022 | 4 | 253 | 0 | 90,768 |
| 2023 | 5 | 204 | 8 (7) | 27,987 |
| 2024 | 10 | 132 | 0 | 68,262 |
| 2025 | 7 | 189 | 0 | 60,279 |
| 2026 | 10 | 214 | 2 (2) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120920 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120920: Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120920
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026