510(k) · Cleared
ClearedNippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hsiner Co., Ltd. · CBK Ventilator, Continuous, Facility Use
Cleared on Aug 12, 2011 as substantially equivalent to K063268 (Hsiner Co., Ltd., 2007) and 1 other predicate after a 379-day review. Its family tree reaches back 6 generations to 2001. 1 of the 20 devices in its family, counting itself, has a Class I recall.
- Decided
- Aug 12, 2011
- Review
- 379 days
- Class
- Class II
- Product code
- CBK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003894 (2001). 19 ancestors in all, the oldest K833786 (1983). No later device cites it as a predicate yet. 1 of the 20 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK003894 Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2001 · Recalled
- 5 generations backK023559 Fisher & Paykel Healthecare Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2003
- 4 generations backK033087 Oracle Oral Mask, Model HC451AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- 3 generations backK040506 Flexifil Series HC431 Full Face Mask, Model HC431AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- 2 generations backK060044 Acute Care Face Mask, Model RT040Fisher & Paykel Healthcare, Ltd. · 2006
- 1 generation backK083122 Hospital Full Face Mask Non Vented, Model: RT041Fisher & Paykel Healthcare, Ltd. · 2009
- This deviceK102120 Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone…Hsiner Co., Ltd. · 2011
Class I recalls in this family
- K063268 Cpap/Vpap Masks, Models 1225, 1205 and 1235direct predicate · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003894 | Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2001 | 6 |
| −5 | K023559 | Fisher & Paykel Healthecare Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| −4 | K033087 | Oracle Oral Mask, Model HC451A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| −3 | K040506 | Flexifil Series HC431 Full Face Mask, Model HC431A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| −2 | K060044 | Acute Care Face Mask, Model RT040 | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| −1 | K083122 | Hospital Full Face Mask Non Vented, Model: RT041 | Fisher & Paykel Healthcare, Ltd. | 2009 | — |
| 0 (this device) | K102120 | Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask… | Hsiner Co., Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 1 |
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 CBK device
- #1 K252663 Inbentus Versatilescore 16.0 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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…loseness of (it 1o the sKin. Sofl, ¢lastic headgear insures a tight comlortable 11t agains( the face, The Hsiner NIPPV Magks are moditications to their CPAP/VPAP Masks (K063268). “These masKs difler from the CPAP/ VPADP mask only in that the vents and anti-nsphyxiation valves have been removed, 8.4, Subs… | 2007 |
| * | K083122 | Hospital Full Face Mask Non Vented, Model: RT041Summary page 2…vices 8.7.1. Design, Materials and [ntended Use The Hsiner NIPPV masks are equivalent in designz materials.and performance o the | Fisher Pavkel's RT41 NIV (ace mask (K083122) and Hsiner's CPAP/VPAP mask, The Hsiner and Fisher Paykel devices aperate on the same principles and have the same intended use.… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 10 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 4 of the 19 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K063268.
How does its category compare?
All CBK devicesCBK Ventilator, Continuous, Facility Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CBK
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CBK
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CBK
14in 2024
Class I (81 since 2007) Class II/III not classified
Adverse event reports per year · CBK
13,991in 2025
MAUDE reports naming product code CBK, 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 | 11 | 142 | 17 | 1,531 |
| 2008 | 18 | 115 | 23 | 1,933 |
| 2009 | 12 | 122 | 8 | 1,766 |
| 2010 | 14 | 150 | 9 | 1,799 |
| 2011 | 13 | 192 | 12 | 1,877 |
| 2012 | 17 | 207 | 2 (1) | 5,509 |
| 2013 | 5 | 277 | 5 (2) | 7,921 |
| 2014 | 5 | 439 | 5 (4) | 7,600 |
| 2015 | 7 | 266 | 6 (4) | 11,876 |
| 2016 | 4 | 323 | 4 (1) | 16,056 |
| 2017 | 6 | 280 | 1 | 14,451 |
| 2018 | 4 | 183 | 3 (3) | 9,849 |
| 2019 | 8 | 435 | 14 (13) | 9,100 |
| 2020 | 5 | 176 | 4 | 11,096 |
| 2021 | 6 | 267 | 21 (19) | 13,322 |
| 2022 | 0 | — | 8 (4) | 15,974 |
| 2023 | 5 | 309 | 4 (3) | 24,928 |
| 2024 | 9 | 203 | 14 (14) | 20,336 |
| 2025 | 4 | 163 | 0 | 13,991 |
| 2026 | 3 | 235 | 15 (13) | — |
What is it indicated for?
The Hsiner NIPPV masks provide a patient interface for application of noninvasive ventilation with ventilators with adequate alarms and safety systems to protect the patient in the event for ventilator failure, These masks are intended for use with spontaneously-breathing adult patients (> 30 kg) with respiratory insufficiency or respiratory failure suitable for noninvasive pressure support ventilation treatment in the hospital/institutional environment (including but not limited to moderate or severe dyspnea; elevated respiratory rates, labored breathing, or paradoxical breathing).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K102120 · printed Nov 4, 2026
Cite this page
510(k) Report. “K102120: Nippv Silicone Face Mask, Nippv Economy Face Mask, Nippv Silicone Nasal Mask Model 10212, 10222, 10202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K102120
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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