510(k) · Cleared
ClearedOpus HC482 Direct 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 Dec 22, 2006 as substantially equivalent to K042403 (Resmed, Ltd., 2004) and 2 other predicates after an 80-day review. Its family tree reaches back 5 generations to 1995. 24 later devices descend from it.
- Decided
- Dec 22, 2006
- Review
- 80 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K952292 (1995). 25 ancestors in all, the oldest K900164 (1990). 24 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK952292 Puritan-Bennett Companion Nasal Cpap SystemPuritan Bennett Corp. · 1995
- 4 generations backK961626 Solo Cpap SystemRespironics, Inc. · 1996
- 3 generations backK973161 Cpap Humidifier (HC 200)Fisher & Paykel Electronics, Ltd. · 1998
- 2 generations backK040941 Cpap Humidifier, Model HC234 (and Related Accessories)Fisher & Paykel Healthcare, Ltd. · 2004
- 1 generation backK050904 Cpap Humidifier, Model HC238JHUFisher & Paykel Healthcare, Ltd. · 2005
- This deviceK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
- Descendant · cites it directly · 15 of its ownK080209 Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008
- Descendant · cites it directly · 14 of its ownK083832 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
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008 · cites it directly15descendants
- K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009 · cites it directly14descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952292 | Puritan-Bennett Companion Nasal Cpap System | Puritan Bennett Corp. | 1995 | — |
| −4 | K961626 | Solo Cpap System | Respironics, Inc. | 1996 | — |
| −3 | K973161 | Cpap Humidifier (HC 200) | Fisher & Paykel Electronics, Ltd. | 1998 | — |
| −2 | K040941 | Cpap Humidifier, Model HC234 (and Related Accessories) | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| −1 | K050904 | Cpap Humidifier, Model HC238JHU | Fisher & Paykel Healthcare, Ltd. | 2005 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K042403 | Mirage SwiftSummary page 1…al Mask Classification Non continuous ventilator IPPB name (21 CFR § 868.5905, product code BZD) Predicate devices K042403 Resmed Mirage Swift TM K061236 Fisher & Paykel Healthcare Flexifit HC432 Full Face… | 2004 |
| * | K061236 | Flexifit HC432 Full Face MaskSummary page 1…tor IPPB name (21 CFR § 868.5905, product code BZD) Predicate devices K042403 Resmed Mirage Swift TM K061236 Fisher & Paykel Healthcare Flexifit HC432 Full Face Mask and K050904 HC238 Fisher & Paykel Healthcar… | 2006 |
| * | K050904 | Cpap Humidifier, Model HC238JHUSummary page 1…K042403 Resmed Mirage Swift TM K061236 Fisher & Paykel Healthcare Flexifit HC432 Full Face Mask and K050904 HC238 Fisher & Paykel Healthcare Cpap Humidifier (predicates for material biocompatibility)… | 2005 |
What descends from it? (24)
See all 245 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 11 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K080209 (Fisher & Paykel Healthcare, Ltd., 2008) has gone furthest, with 15 descendants of its own.
- 8 other devices also cite its predicate K042403.
How does its category compare?
All BZD devicesBZD Ventilator, Non-Continuous (Respirator): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Opus HC482 Direct Nasal Mask is intended for multiple patient or single patient adult use by individuals who have been diagnosed by a physician as requiring CPAP or Bilevel ventilator treatment in the home, hospital or other clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063036 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063036: Opus HC482 Direct 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/K063036
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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