510(k) · Cleared
ClearedF&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
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 Jun 2, 2020 as substantially equivalent to K161412 (Fisher & Paykel Healthcare, Ltd., 2017) after a 139-day review. Its family tree reaches back 10 generations to 1995. 5 later devices descend from it.
- Decided
- Jun 2, 2020
- Review
- 139 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K952292 (1995). 30 ancestors in all, the oldest K900164 (1990). 5 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 6 generations between
- 3 generations backK083832 Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009
- 2 generations backK120027 Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited · 2012
- 1 generation backK161412 F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd. · 2017
- This deviceK200089 F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P…Fisher & Paykel Healthcare, Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK233415 DELTAWAVE Nasal Pillows SystemRemsleep Holdings · 2024
- Descendant · cites it directly · 1 of its ownK223696 F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK253939 DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK243583 F&P Nova Nasal MaskFisher & Paykel Healthcare Limited · 2025
- Descendant · 2 generations on · 0 of its ownK233829 Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows…Fisher and Paykel Healthcare Limited · 2024
Show all 10 generations
- Root · 10 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 9 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 8 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 7 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 6 generations backK050904 Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd. · 2005
- 5 generations backK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
- 4 generations backK080209 Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008
- 3 generations backK083832 Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009
- 2 generations backK120027 Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited · 2012
- 1 generation backK161412 F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd. · 2017
- This deviceK200089 F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P…Fisher & Paykel Healthcare, Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K233415DELTAWAVE Nasal Pillows SystemRemsleep Holdings · 2024 · cites it directly1descendant
- K223696F&P Solo Mask RangeFisher & Paykel Healthcare, Ltd. · 2023 · cites it directly1descendant
- K253939DeltaWave Nasal Pillow SystemRemSleep Holdings, Inc. · 2026 · 2 generations on0descendants
- K243583F&P Nova Nasal MaskFisher & Paykel Healthcare Limited · 2025 · cites it directly0descendants
- K233829Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model…Fisher and Paykel Healthcare Limited · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −9 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −8 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −7 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −6 | K050904 | Cpap Humidifier, Model HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −5 | K063036 | Opus HC482 Direct Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| −4 | K080209 | Fisher and Paykel Healthcare Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −3 | K083832 | Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2009 | — |
| −2 | K120027 | Pilairo Nasal Pillows Mask | Fisher & Paykel Healthcare Limited | 2012 | — |
| −1 | K161412 | F&P Brevida™ Nasal Pillows Mask | Fisher & Paykel Healthcare, Ltd. | 2017 | — |
| 0 (this device) | K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora… | Fisher & Paykel Healthcare, Ltd. | 2020 | — |
| +1 | K233415 | DELTAWAVE Nasal Pillows System | Remsleep Holdings | 2024 | — |
| +1 | K223696 | F&P Solo Mask Range | Fisher & Paykel Healthcare, Ltd. | 2023 | — |
| +2 | K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | 2026 | — |
| +1 | K243583 | F&P Nova Nasal Mask | Fisher & Paykel Healthcare Limited | 2025 | — |
| +2 | K233829 | Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium… | Fisher and Paykel Healthcare Limited | 2024 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K161412 | F&P Brevida™ Nasal Pillows MaskSummary page 4…Class II (21 CFR §868.5905) Product code BZD (Anaesthesiology) Predicate device F&P Brevida™ Nasal Pillows Mask (K161412) Page 1 of 7 F&P Evora Nasal… | 2017 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 30 ancestors have a recall of any class.
- Of its descendants, K233415 (Remsleep Holdings, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
A-Model:
The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal Mask is intended for single patient use in the home.
SL Model:
The F&P Evora Nasal Mask is intended to be used by adults weighing ≥66lbs (30kgs) who have been prescribed non-invasive positive airway pressure therapy such as CPAP or bilevel by a physician. The F&P Evora Nasal 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 as stated in the FDA summary.
https://510kreport.com/device/K200089 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200089: F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200089
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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