510(k) · Cleared
ClearedVpap Malibu with H2I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · BZD Ventilator, Non-Continuous (Respirator)
Cleared on Sep 8, 2006 as substantially equivalent to K030843 (Resmed, Ltd., 2003) and 1 other predicate after a 32-day review. Its family tree reaches back 3 generations to 1997. 41 later devices descend from it.
- Decided
- Sep 8, 2006
- Review
- 32 days
- Class
- Class II
- Product code
- BZD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K971260 (1997). 6 ancestors in all, the oldest K961783 (1996). 41 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 2 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 1 generation backK030843 Vpap IiiResmed, Ltd. · 2003
- This deviceK062291 Vpap Malibu with H2IResmed, Ltd. · 2006
- Descendant · cites it directly · 40 of its ownK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- Descendant · cites it directly · 38 of its ownK080131 Vpap STResmed, Ltd. · 2008
- Descendant · 2 generations on · 33 of its ownK082605 Vpap Auto with Humidaire 3IResmed, Ltd. · 2009
- Descendant · 2 generations on · 31 of its ownK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- Descendant · 2 generations on · 18 of its ownK092186 Vpap TXResmed, Ltd. · 2009
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K071171Vpap Auto with H3IResmed, Ltd. · 2007 · cites it directly40descendants
- K080131Vpap STResmed, Ltd. · 2008 · cites it directly38descendants
- K082605Vpap Auto with Humidaire 3IResmed, Ltd. · 2009 · 2 generations on33descendants
- K091947S8 Aspen with H4I PlusResmed, Ltd. · 2009 · 2 generations on31descendants
- K092186Vpap TXResmed, Ltd. · 2009 · 2 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −2 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −1 | K030843 | Vpap Iii | Resmed, Ltd. | 2003 | — |
| 0 (this device) | K062291 | Vpap Malibu with H2I | Resmed, Ltd. | 2006 | — |
| +1 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| +1 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| +2 | K082605 | Vpap Auto with Humidaire 3I | Resmed, Ltd. | 2009 | — |
| +2 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
| +2 | K092186 | Vpap TX | Resmed, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K030843 | Vpap IiiSummary page 1…mmon/Usual Name Noncontinuous ventilator (IPPS). Proprietary Name VPAP Malibu Predicate Device(s) VPAP Ill (K030843) - Primary AutoSet Spirit (K0l 3843) -Secondary Reason for submission… | 2003 |
| * | K013843 | Autoset Spirit Cpap SystemSummary page 2…wer system that generates airway pressures as required to maintain an 'air splint" for effective treatment of OSA. The system comprises the Flow Generator, HumidAire 2i (K013843), patient tubing, mask (patient interface) and ResLink with Smart Media Card (K024191). The performance and functional characteri… | 2002 |
What descends from it? (41)
See all 412 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 9 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K071171 (Resmed, Ltd., 2007) has gone furthest, with 40 descendants of its own.
- 2 other devices also cite its predicate K030843.
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 VPAP Malibu is indicated for the treatment of adult patients with Obstructive Sleep Apnoea (OSA).
It is intended for use in the hospital and home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062291 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062291: Vpap Malibu with H2I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062291
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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