510(k) · Cleared
ClearedF&P Evora Full Face Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Mar 18, 2022 as substantially equivalent to K190713 (Fisher & Paykel Healthcare, Ltd., 2019) after a 231-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Mar 18, 2022
- Review
- 231 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K952292 (1995). 31 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet.
- Root · 11 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 7 generations between
- 3 generations backK121597 Eson Nasal MaskFisher & Paykel Healthcare Limited · 2012
- 2 generations backK130328 F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited · 2013
- 1 generation backK190713 F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera…Fisher & Paykel Healthcare, Ltd. · 2019
- This deviceK212371 F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd. · 2022
Show all 11 generations
- Root · 11 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 10 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 9 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 8 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 7 generations backK050904 Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd. · 2005
- 6 generations backK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
- 5 generations backK080209 Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008
- 4 generations backK083832 Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009
- 3 generations backK121597 Eson Nasal MaskFisher & Paykel Healthcare Limited · 2012
- 2 generations backK130328 F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited · 2013
- 1 generation backK190713 F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera…Fisher & Paykel Healthcare, Ltd. · 2019
- This deviceK212371 F&P Evora Full Face MaskFisher & Paykel Healthcare, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −10 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −9 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −8 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −7 | K050904 | Cpap Humidifier, Model HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −6 | K063036 | Opus HC482 Direct Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| −5 | K080209 | Fisher and Paykel Healthcare Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −4 | K083832 | Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2009 | — |
| −3 | K121597 | Eson Nasal Mask | Fisher & Paykel Healthcare Limited | 2012 | — |
| −2 | K130328 | F&P Simplus Full Face Mask | Fisher & Paykel Healthcare Limited | 2013 | — |
| −1 | K190713 | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full… | Fisher & Paykel Healthcare, Ltd. | 2019 | — |
| 0 (this device) | K212371 | F&P Evora Full Face Mask | Fisher & Paykel Healthcare, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 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.
Planning a device in BZD? 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? (1)
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 |
|---|---|---|---|
| * | K190713 | F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face…Summary page 4…Class II (21 CFR §868.5905) Product Code BZD III. PREDICATE DEVICE • Predicate device: o F&P Vitera™ Full Face Mask, K190713 • Reference devices: o F&P Evora™ Nasal Mask, K200089 Used to support claims of subs… | 2019 |
| † | K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 31 ancestors have a recall of any class.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 F&P Evora Full Face mask is intended to be used by adults weighing > 661bs (30kgs) who have been diagnosed by a physician as requiring CPAP or Bi-Level therapy. The F&P Evora Full Face mask is intended for single patient use in the home and for multiple patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.
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/K212371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212371: F&P Evora Full Face Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212371
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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