510(k) · Cleared
Recalled · 2006Oracle Oral Mask, Model HC451A
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 Jan 14, 2004 as substantially equivalent to K023559 (Fisher & Paykel Healthcare, Ltd., 2003) after a 107-day review. Its family tree reaches back 2 generations to 2001. 39 later devices descend from it. It has been recalled 6 times.
- Decided
- Jan 14, 2004
- Review
- 107 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003894 (2001). 39 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK003894 Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2001 · Recalled
- 1 generation backK023559 Fisher & Paykel Healthecare Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2003
- This deviceK033087 Oracle Oral Mask, Model HC451AFisher & Paykel Healthcare, Ltd. · 2004
- Descendant · cites it directly · 38 of its ownK040506 Flexifil Series HC431 Full Face Mask, Model HC431AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 25 of its ownK061236 Flexifit HC432 Full Face MaskFisher & Paykel Healthcare, Ltd. · 2006
- Descendant · 2 generations on · 24 of its ownK063036 Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006
- Descendant · 2 generations on · 15 of its ownK080209 Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008
- Descendant · 3 generations on · 14 of its ownK083832 Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K040506Flexifil Series HC431 Full Face Mask, Model HC431AFisher & Paykel Healthcare, Ltd. · 2004 · cites it directly38descendants
- K061236Flexifit HC432 Full Face MaskFisher & Paykel Healthcare, Ltd. · 2006 · cites it directly25descendants
- K063036Opus HC482 Direct Nasal MaskFisher & Paykel Healthcare, Ltd. · 2006 · 2 generations on24descendants
- K080209Fisher and Paykel Healthcare Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2008 · 2 generations on15descendants
- K083832Zest Nasal MaskFisher & Paykel Healthcare, Ltd. · 2009 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003894 | Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2001 | 6 |
| −1 | K023559 | Fisher & Paykel Healthecare Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| 0 (this device) | K033087 | Oracle Oral Mask, Model HC451A | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +1 | K040506 | Flexifil Series HC431 Full Face Mask, Model HC431A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| +1 | K061236 | Flexifit HC432 Full Face Mask | Fisher & Paykel Healthcare, Ltd. | 2006 | — |
| +2 | 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 | — |
| +3 | K083832 | Zest Nasal Mask | Fisher & Paykel Healthcare, Ltd. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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), 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 |
|---|---|---|---|
| * | K023559 | Fisher & Paykel Healthecare Oracle Oral MaskSummary page 1…esiology Devices, 21 CFR §868.5905 (Class II) Predicate Device: Fisher & Paykel Healthcare, LTD., Oracle Oral Mask, Model 900HC451, K023559 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §80… | 2003 |
What descends from it? (39)
See all 392 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)
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?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K040506 (Fisher & Paykel Healthcare, Ltd., 2004) has gone furthest, with 38 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) | — |
What is it indicated for?
The Fisher & Paykel Healthcare Oracle Oral Mask is an accessory to a Noncontinuous ventilator (IPPB) as per BZD, 21 CFR §868.5905.
The Oral Mask is indicated for use by adults requiring CPAP or Bilevel ventilator treatment in home, hospital and laboratory environments for the treatment of Obstructive Sleep Apnea (OSA). It constitutes the patient to ventilator interface in a non-continuous ventilator system. The device administers positive airway pressure orally. The Oral Mask is a reusable device for use on the prescription of a suitably qualified physician. The Oral Mask may be reprocessed for multi-patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033087: Oracle Oral Mask, Model HC451A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033087
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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