510(k) · Cleared
ClearedZest Petite 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 24, 2011 as substantially equivalent to K083832 (Fisher & Paykel Healthcare, Ltd., 2009) and 2 other predicates after an 87-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Mar 24, 2011
- Review
- 87 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K952292 (1995). 36 ancestors in all, the oldest K833786 (1983). No later device cites it as a predicate yet.
- Root · 8 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 7 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 6 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 5 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 4 generations backK050904 Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd. · 2005
- 3 generations backK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
- 2 generations backK080209 Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008
- 1 generation backK083832 Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009
- This deviceK103786 Zest Petite Nasal MaskFisher & Paykel Healthcare, Ltd. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −7 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −6 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −5 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −4 | K050904 | Cpap Humidifier, Model HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −3 | K063036 | Opus HC482 Direct Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| −2 | K080209 | Fisher and Paykel Healthcare Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −1 | K083832 | Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2009 | — |
| 0 (this device) | K103786 | Zest Petite Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K083832 | Zest Nasal MaskSummary page 1…Petite Nasal Mask Common Name Nasal Mask Classification Non continuous ventilator IPPB Name (21 CFR § 868.5905, product code BZD) K083832 Fisher & Paykel Healthcare Zest Nasal Mask Predicate K092835 Respironics ComfortGel Blue Nasal Mask Devices… | 2009 |
| * | K092835 | Comfortgel Nasal MaskSummary page 1…n continuous ventilator IPPB Name (21 CFR § 868.5905, product code BZD) K083832 Fisher & Paykel Healthcare Zest Nasal Mask Predicate K092835 Respironics ComfortGel Blue Nasal Mask Devices K061236 Fisher & Paykel Healthcare Flexifit HC432 Full Face… | 2010 |
| * | K061236 | Flexifit HC432 Full Face MaskSummary page 1…t code BZD) K083832 Fisher & Paykel Healthcare Zest Nasal Mask Predicate K092835 Respironics ComfortGel Blue Nasal Mask Devices K061236 Fisher & Paykel Healthcare Flexifit HC432 Full Face Mask (predicate for material biocompatibility)… | 2006 |
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 16 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 4 of the 36 ancestors have a recall of any class.
- 2 other devices also cite its predicate K083832.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Petite Nasal Mask is intended to be used by individuals greater than 661bs (30kg) who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The ZestrTM Petite Nasal Mask is intended for Single Patient Use in the home and 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/K103786 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103786: Zest Petite Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103786
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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