510(k) · Cleared
ClearedZest Nasal 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 16, 2009 as substantially equivalent to K080209 (Fisher & Paykel Healthcare, Ltd., 2008) and 1 other predicate after an 83-day review. Its family tree reaches back 7 generations to 1995. 14 later devices descend from it.
- Decided
- Mar 16, 2009
- Review
- 83 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K952292 (1995). 27 ancestors in all, the oldest K900164 (1990). 14 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 6 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 5 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 4 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 3 generations backK050904 Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd. · 2005
- 2 generations backK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
- 1 generation backK080209 Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008
- This deviceK083832 Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009
- Descendant · cites it directly · 7 of its ownK120027 Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited · 2012
- Descendant · 2 generations on · 6 of its ownK161412 F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd. · 2017
- Descendant · 3 generations on · 5 of its ownK200089 F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P…Fisher & Paykel Healthcare, Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK121597 Eson Nasal MaskFisher & Paykel Healthcare Limited · 2012
- Descendant · 2 generations on · 2 of its ownK130328 F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited · 2012 · cites it directly7descendants
- K161412F&P Brevida™ Nasal Pillows MaskFisher & Paykel Healthcare, Ltd. · 2017 · 2 generations on6descendants
- K200089F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask…Fisher & Paykel Healthcare, Ltd. · 2020 · 3 generations on5descendants
- K121597Eson Nasal MaskFisher & Paykel Healthcare Limited · 2012 · cites it directly4descendants
- K130328F&P Simplus Full Face MaskFisher & Paykel Healthcare Limited · 2013 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −6 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −5 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −4 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −3 | K050904 | Cpap Humidifier, Model HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −2 | K063036 | Opus HC482 Direct Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| −1 | K080209 | Fisher and Paykel Healthcare Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| 0 (this device) | K083832 | Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2009 | — |
| +1 | K120027 | Pilairo Nasal Pillows Mask | Fisher & Paykel Healthcare Limited | 2012 | — |
| +2 | K161412 | F&P Brevida™ Nasal Pillows Mask | Fisher & Paykel Healthcare, Ltd. | 2017 | — |
| +3 | K200089 | F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora… | Fisher & Paykel Healthcare, Ltd. | 2020 | — |
| +1 | K121597 | Eson Nasal Mask | Fisher & Paykel Healthcare Limited | 2012 | — |
| +2 | K130328 | F&P Simplus Full Face Mask | Fisher & Paykel Healthcare Limited | 2013 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K080209 | Fisher and Paykel Healthcare Zest Nasal MaskSummary page 1…Nasal Mask Classification Non continuous ventilator IPPB Name (21 CFR § 868.5905, product code BZD) Predicate K080209 Fisher & Paykel Healthcare Zest Nasal Mask Devices K063036 Fisher & Paykel Healthcare HC482 Direct Nasal Mask… | 2008 |
| * | K063036 | Opus HC482 Direct Nasal MaskSummary page 1…e (21 CFR § 868.5905, product code BZD) Predicate K080209 Fisher & Paykel Healthcare Zest Nasal Mask Devices K063036 Fisher & Paykel Healthcare HC482 Direct Nasal Mask. Revised -13 February 2009… | 2006 |
What descends from it? (14)
See all 143 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 14 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 27 ancestors have a recall of any class.
- Of its descendants, K120027 (Fisher & Paykel Healthcare Limited, 2012) has gone furthest, with 7 descendants 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. 2009, 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 Zest TM Nasal Mask is intended to be used by individuals who have been diagnosed. by a physician as requiring CPAP or Bi-level ventilator treatment.. The Zest TM Nasal Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult 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/K083832 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083832: Zest Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083832
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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