510(k) · Cleared
Recalled · 2006Flexifil Series HC431 Full Face Mask, Model HC431A
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 May 5, 2004 as substantially equivalent to K023244 (Resmed, Ltd., 2002) and 1 other predicate after a 68-day review. Its family tree reaches back 3 generations to 2001. 38 later devices descend from it. It has been recalled 6 times.
- Decided
- May 5, 2004
- Review
- 68 days
- Class
- Class II
- Product code
- BZD
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 3 generations to K003894 (2001). 6 ancestors in all, the oldest K982530 (1998). 38 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK003894 Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2001 · Recalled
- 2 generations backK023559 Fisher & Paykel Healthecare Oracle Oral MaskFisher & Paykel Healthcare, Ltd. · 2003
- 1 generation backK033087 Oracle Oral Mask, Model HC451AFisher & Paykel Healthcare, Ltd. · 2004 · Recalled
- This deviceK040506 Flexifil Series HC431 Full Face Mask, Model HC431AFisher & Paykel Healthcare, Ltd. · 2004
- 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
- Descendant · 3 generations on · 7 of its ownK120027 Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited · 2012
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- 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
- K120027Pilairo Nasal Pillows MaskFisher & Paykel Healthcare Limited · 2012 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003894 | Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2001 | 6 |
| −2 | K023559 | Fisher & Paykel Healthecare Oracle Oral Mask | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| −1 | K033087 | Oracle Oral Mask, Model HC451A | Fisher & Paykel Healthcare, Ltd. | 2004 | 6 |
| 0 (this device) | K040506 | Flexifil Series HC431 Full Face Mask, Model HC431A | Fisher & Paykel Healthcare, Ltd. | 2004 | — |
| +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 | — |
| +3 | K120027 | Pilairo Nasal Pillows Mask | Fisher & Paykel Healthcare Limited | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K023244 | Mirage Full Face Mask Series 2Summary page 1…or (IPPB) - 73 BZD Anesthesiology Devices, 21 CFR §868.5905 (Class II) Predicate Devices: Resmed, Full Face Mask Series 2, K023244 Fisher & Paykel Healthcare, Oracle Oral Mask, K033087 (predic… | 2002 |
| * | K033087 | Oracle Oral Mask, Model HC451ASummary page 1…5905 (Class II) Predicate Devices: Resmed, Full Face Mask Series 2, K023244 Fisher & Paykel Healthcare, Oracle Oral Mask, K033087 (predicate for non-rebreathing valve and biocompatibility) This summary of 510(k) safety and e… | 2004 |
What descends from it? (38)
See all 385 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 7 months on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K061236 (Fisher & Paykel Healthcare, Ltd., 2006) has gone furthest, with 25 descendants of its own.
- 11 other devices also cite its predicate K023244.
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 Flexifit TM Series HC431 Full Face Mask is an accessory to a Noncontinuous ventilator (IPPB) as per 73 BZD, 21 CFR §868.5905.
The Flexifit TM Series HC431 Full Face 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 noncontinuous ventilator system. The device administers positive airway pressure via a mask which covers the nose and mouth. The HC431 Full Face Mask is a multi-patient reusable device for use on the prescription of a suitably qualified physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040506 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040506: Flexifil Series HC431 Full Face Mask, Model HC431A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040506
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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