510(k) · Cleared
ClearedF&P Eson 2 Nasal Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare Limited · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 20, 2016 as substantially equivalent to K121597 (Fisher & Paykel Healthcare Limited, 2012) after a 288-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Sep 20, 2016
- Review
- 288 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K952292 (1995). 29 ancestors in all, the oldest K900164 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 5 generations between
- 3 generations backK080209 Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008
- 2 generations backK083832 Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009
- 1 generation backK121597 Eson Nasal MaskFisher & Paykel Healthcare Limited · 2012
- This deviceK153505 F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited · 2016
Show all 9 generations
- Root · 9 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 8 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 7 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 6 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 5 generations backK050904 Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd. · 2005
- 4 generations backK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
- 3 generations backK080209 Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008
- 2 generations backK083832 Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009
- 1 generation backK121597 Eson Nasal MaskFisher & Paykel Healthcare Limited · 2012
- This deviceK153505 F&P Eson 2 Nasal MaskFisher & Paykel Healthcare Limited · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −8 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −7 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −6 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −5 | K050904 | Cpap Humidifier, Model HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| −4 | K063036 | Opus HC482 Direct Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| −3 | K080209 | Fisher and Paykel Healthcare Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2008 | — |
| −2 | K083832 | Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2009 | — |
| −1 | K121597 | Eson Nasal Mask | Fisher & Paykel Healthcare Limited | 2012 | — |
| 0 (this device) | K153505 | F&P Eson 2 Nasal Mask | Fisher & Paykel Healthcare Limited | 2016 | — |
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 |
|---|---|---|---|
| * | K121597 | Eson Nasal MaskSummary page 4…Class II (21 CFR §868.5905) Product code BZD (Anaesthesiology) Predicate device Eson™ Nasal Mask (K121597) Fisher & Paykel Healthcare F&P Eson™ 2 Nasal Mask 510(k) Notification 2 Device Desc… | 2012 |
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 21 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 29 ancestors have a recall of any class.
- 1 other device also cites its predicate K121597.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Eson™ 2 Nasal Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-level therapy. The F&P Eson™ 2 Nasal Mask is intended for single patient adult (≥ 66lb (30kg)) use in the home and for 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/K153505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153505: F&P Eson 2 Nasal Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153505
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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