510(k) · Cleared
ClearedMariana Minerva; Mariana Nimbus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Pty, Ltd. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Feb 23, 2026 as substantially equivalent to K161492 (Resmed, Ltd., 2017) after a 269-day review. Its family tree reaches back 12 generations to 1997. 3 of the 104 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 23, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K971260 (1997). 103 ancestors in all, the oldest K883038 (1988). No later device cites it as a predicate yet. 3 of the 104 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 8 generations between
- 3 generations backK113288 Vpap ST-aResmed, Ltd. · 2012
- 2 generations backK153061 Juno VPAP ST-AResmed, Ltd. · 2016
- 1 generation backK161492 Juno VPAP ST-AResmed, Ltd. · 2017
- This deviceK251661 Mariana Minerva; Mariana NimbusResmed Pty, Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 11 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 10 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 9 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 8 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 7 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 6 generations backK080131 Vpap STResmed, Ltd. · 2008
- 5 generations backK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- 4 generations backK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- 3 generations backK113288 Vpap ST-aResmed, Ltd. · 2012
- 2 generations backK153061 Juno VPAP ST-AResmed, Ltd. · 2016
- 1 generation backK161492 Juno VPAP ST-AResmed, Ltd. · 2017
- This deviceK251661 Mariana Minerva; Mariana NimbusResmed Pty, Ltd. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −11 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −10 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −9 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −8 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −7 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −6 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| −5 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
| −4 | K102513 | S9 Vpap ST with H5I | Resmed, Ltd. | 2011 | — |
| −3 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
| −2 | K153061 | Juno VPAP ST-A | Resmed, Ltd. | 2016 | — |
| −1 | K161492 | Juno VPAP ST-A | Resmed, Ltd. | 2017 | — |
| 0 (this device) | K251661 | Mariana Minerva; Mariana Nimbus | Resmed Pty, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 11 | 2 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 1 |
| 2003 | 3 | 0 |
| 2004 | 7 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2011 | 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.
3 devices in this family have a Class I recall. 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 MNS device
- #1 K252078 BreathePal Bilevel (GFM50-MD2201)score 14.0 · 11 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 |
|---|---|---|---|
| * | K161492 | Juno VPAP ST-ASummary page 5…21 CFR §868.5895, 73 MNS (Class II) Classification Name: Continuous Ventilator Product Code: MNS Predicate Device: Juno VPAP ST-A (K161492) Reference Device N/A Submission Reason: New device… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K013642AVEABird Products Corp. · 2002 · 8 generations back · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 8 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 9 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 21 of the 103 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All MNS devicesMNS Ventilator, Continuous, Non-Life-Supporting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MNS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNS
115in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNS
1in 2008
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MNS
1,790in 2025
MAUDE reports naming product code MNS, 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 | 4 | 90 | 2 | 9 |
| 2008 | 0 | — | 1 | 7 |
| 2009 | 4 | 92 | 0 | 8 |
| 2010 | 4 | 124 | 0 | 9 |
| 2011 | 3 | 140 | 0 | 9 |
| 2012 | 5 | 111 | 0 | 12 |
| 2013 | 3 | 115 | 0 | 18 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 50 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 20 |
| 2018 | 1 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 275 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 256 |
| 2022 | 1 | — | 0 | 2,514 |
| 2023 | 1 | — | 0 | 1,320 |
| 2024 | 1 | — | 0 | 1,571 |
| 2025 | 0 | — | 0 | 1,790 |
| 2026 | 3 | 269 | 1 (1) | — |
What is it indicated for?
The Mariana Minerva is intended to provide non-invasive ventilation, for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory impairment or obstructive sleep apnoea (OSA). It is intended for home and hospital use.
The Mariana Nimbus is intended to provide non-invasive ventilation, for patients weighing more than 30 lb (13 kg) or more than 66 lb (30 kg) in iVAPS mode with respiratory impairment or obstructive sleep apnoea (OSA). It is intended for home and hospital use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251661: Mariana Minerva; Mariana Nimbus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251661
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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