510(k) · Cleared
Recalled · 2006Oracle Oral 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 Jun 25, 2001 after a 189-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 41 later devices descend from it. It has been recalled 6 times.
- Decided
- Jun 25, 2001
- Review
- 189 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 6
- Predicates
- 0
41 later devices descend from it, 1 citing it directly.
- This deviceK003894 Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2001
- Descendant · cites it directly · 40 of its ownK023559 Fisher & Paykel Healthecare Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2003
- Descendant · 2 generations on · 39 of its ownK033087 Oracle Oral Mask, Model HC451AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- Descendant · 3 generations on · 38 of its ownK040506 Flexifil Series HC431 Full Face Mask, Model HC431AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- Descendant · 3 generations on · 25 of its ownK061236 Flexifit HC432 Full Face MaskFisher & Paykel Healthcare, Ltd. · 2006
- Descendant · 4 generations on · 24 of its ownK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K023559Fisher & Paykel Healthecare Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2003 · cites it directly40descendants
- K033087Oracle Oral Mask, Model HC451AFisher & Paykel Healthcare, Ltd. · 2004 · 2 generations on39descendants
- K040506Flexifil Series HC431 Full Face Mask, Model HC431AFisher & Paykel Healthcare, Ltd. · 2004 · 3 generations on38descendants
- K061236Flexifit HC432 Full Face MaskFisher & Paykel Healthcare, Ltd. · 2006 · 3 generations on25descendants
- K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006 · 4 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003894 | Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2001 | — |
| +1 | K023559 | Fisher & Paykel Healthecare Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| +2 | K033087 | Oracle Oral Mask, Model HC451A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| +3 | K040506 | Flexifil Series HC431 Full Face Mask, Model HC431A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| +3 | K061236 | Flexifit HC432 Full Face Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| +4 | K063036 | Opus HC482 Direct Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (41)
See all 411 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023559 | Fisher & Paykel Healthecare Oracle Oral Mask | 2003 | 40 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2006 | Not classified | Z-0974-2007 | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and… |
| Nov 24, 2006 | Not classified | Z-0970-2007 | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and… |
| Nov 24, 2006 | Not classified | Z-0971-2007 | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and… |
| Nov 24, 2006 | Not classified | Z-0973-2007 | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and… |
| Nov 24, 2006 | Not classified | Z-0969-2007 | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and… |
| Nov 24, 2006 | Not classified | Z-0972-2007 | Other | Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023559 (Fisher & Paykel Healthcare, Ltd., 2003) has gone furthest, with 40 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.
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) | — |
https://510kreport.com/device/K003894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003894: Oracle Oral Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003894
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026