510(k) · Cleared
ClearedJuno VPAP ST-A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed, Ltd. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Jan 19, 2017 as substantially equivalent to K153061 (Resmed, Ltd., 2016) after a 232-day review. Its family tree reaches back 11 generations to 1997. 3 of the 104 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Jan 19, 2017
- Review
- 232 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K971260 (1997). 102 ancestors in all, the oldest K883038 (1988). 1 later device descends from it, 1 citing it directly. 3 of the 104 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 7 generations between
- 3 generations backK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- 2 generations backK113288 Vpap ST-aResmed, Ltd. · 2012
- 1 generation backK153061 Juno VPAP ST-AResmed, Ltd. · 2016
- This deviceK161492 Juno VPAP ST-AResmed, Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK251661 Mariana Minerva; Mariana NimbusResmed Pty, Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 10 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 9 generations backK024191 S7 Elite and Autoset Spirit Cpap Systems with ReslinkResmed, Ltd. · 2003
- 8 generations backK033841 Resmed S8 Prime Cpap SystemResmed, Ltd. · 2004 · Recalled
- 7 generations backK041209 Resmed S8 Pioneer Cpap SystemResmed, Ltd. · 2004 · Recalled
- 6 generations backK071171 Vpap Auto with H3IResmed, Ltd. · 2007
- 5 generations backK080131 Vpap STResmed, Ltd. · 2008
- 4 generations backK091947 S8 Aspen with H4I PlusResmed, Ltd. · 2009
- 3 generations backK102513 S9 Vpap ST with H5IResmed, Ltd. · 2011
- 2 generations backK113288 Vpap ST-aResmed, Ltd. · 2012
- 1 generation backK153061 Juno VPAP ST-AResmed, Ltd. · 2016
- This deviceK161492 Juno VPAP ST-AResmed, Ltd. · 2017
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −10 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −9 | K024191 | S7 Elite and Autoset Spirit Cpap Systems with Reslink | Resmed, Ltd. | 2003 | — |
| −8 | K033841 | Resmed S8 Prime Cpap System | Resmed, Ltd. | 2004 | 1 |
| −7 | K041209 | Resmed S8 Pioneer Cpap System | Resmed, Ltd. | 2004 | 1 |
| −6 | K071171 | Vpap Auto with H3I | Resmed, Ltd. | 2007 | — |
| −5 | K080131 | Vpap ST | Resmed, Ltd. | 2008 | — |
| −4 | K091947 | S8 Aspen with H4I Plus | Resmed, Ltd. | 2009 | — |
| −3 | K102513 | S9 Vpap ST with H5I | Resmed, Ltd. | 2011 | — |
| −2 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
| −1 | K153061 | Juno VPAP ST-A | Resmed, Ltd. | 2016 | — |
| 0 (this device) | K161492 | Juno VPAP ST-A | Resmed, Ltd. | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 K251661 Mariana Minerva; Mariana Nimbusscore 14.2 · 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 |
|---|---|---|---|
| * | K153061 | Juno VPAP ST-ASummary page 4…es, Continuous Ventilator Regulatory Class Class II Product Code MNS Predicate Device ResMed Juno VPAP ST-A (K153061) January, 2017 Page 1 of 5… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251661 | Mariana Minerva; Mariana Nimbus | 2026 | 0 |
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 · 7 generations back · ◆ in the 2002 ancestors bar of FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 7 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 · 8 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 21 of the 102 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K251661 (Resmed Pty, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153061.
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. 2017, 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 Juno VPAP ST-A is indicated to provide noninvasive ventilation for patients weighing more than 30lbs (13 kg) with respiratory insufficiency or obstructive sleep apnoea (OSA).
The iVAPS mode is indicated for patients weighing more than 66lbs (30 kg).
The Juno VPAP ST-A is intended for home and hospital use.
The humidifier is intended for single patient use in the home environment and re-use in a hospital/institutional environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161492 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161492: Juno VPAP ST-A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161492
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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