510(k) · Cleared
ClearedVpap Iii ST-a/Kidsta Mask System
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 Apr 7, 2006 as substantially equivalent to K033276 (Resmed, Ltd., 2004) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1996. 10 of the 58 devices in its family, counting itself, have a Class I recall. 53 later devices descend from it.
- Decided
- Apr 7, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- MNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961783 (1996). 4 ancestors in all. 53 later devices descend from it, 8 citing it directly. 10 of the 58 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK961783 Sullivan Vpap II ST Nasal Vpap SystemResmed, Ltd. · 1996
- 1 generation backK031047 Mirage Vista MaskResmed, Ltd. · 2003
- This deviceK060105 Vpap Iii ST-a/Kidsta Mask SystemResmed, Ltd. · 2006
- Descendant · cites it directly · 30 of its ownK063533 Bipap SynchronyRespironics, Inc. · 2007
- Descendant · 2 generations on · 28 of its ownK071509 Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · Recalled
- Descendant · cites it directly · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · cites it directly · 13 of its ownK063540 Bipap AutosvRespironics, Inc. · 2007
- Descendant · 3 generations on · 11 of its ownK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 53 · See all- K063533Bipap SynchronyRespironics, Inc. · 2007 · cites it directly30descendants
- K071509Bipap Synchrony 2 Ventilatory Support SystemRespironics Inc., Sleep & Home Respiratory Group · 2007 · 2 generations on28descendants
- K103167Stellar 150Resmed Germany, Inc. · 2011 · cites it directly20descendants
- K063540Bipap AutosvRespironics, Inc. · 2007 · cites it directly13descendants
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961783 | Sullivan Vpap II ST Nasal Vpap System | Resmed, Ltd. | 1996 | — |
| −1 | K031047 | Mirage Vista Mask | Resmed, Ltd. | 2003 | — |
| 0 (this device) | K060105 | Vpap Iii ST-a/Kidsta Mask System | Resmed, Ltd. | 2006 | — |
| +1 | K063533 | Bipap Synchrony | Respironics, Inc. | 2007 | — |
| +2 | K071509 | Bipap Synchrony 2 Ventilatory Support System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | 2 |
| +1 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +1 | K063540 | Bipap Autosv | Respironics, Inc. | 2007 | — |
| +3 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 2 |
| 2010 | 5 | 1 |
| 2011 | 5 | 2 |
| 2012 | 10 | 2 |
| 2013 | 3 | 1 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 1 |
| 2020 | 2 | 0 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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.
10 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? (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 |
|---|---|---|---|
| * | K033276 | Vpap Iii ST-aSummary page 1…or, Passive Exhalation Port, Non-Critical Care. 21 CFR868.5895 Product Code 73MNS Predicate Devices: VPAP III ST-A (K033276) Mirage VISTA Mask (K031047) Reason for submission Include pediatric (7 years and older, > 40 l… | 2004 |
| * | K031047 | Mirage Vista MaskSummary page 1…21 CFR868.5895 Product Code 73MNS Predicate Devices: VPAP III ST-A (K033276) Mirage VISTA Mask (K031047) Reason for submission Include pediatric (7 years and older, > 40 lbs) indication. Intended Use: The VPAP I… | 2003 |
What descends from it? (53)
See all 538 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063533 | Bipap Synchrony | 2007 | 30 |
| K103167 | Stellar 150 | 2011 | 20 |
| K063540 | Bipap Autosv | 2007 | 13 |
| K090935 | Minime Pediatric Mask | 2009 | 5 |
| K120920 | Hsiner Cpap Silicone Nasal Mask Size XS/Petite Hsiner Nasal Pillow Mask Hsiner Infant… | 2012 | 1 |
| K121692 | Minime 2 Nasal Mask | 2012 | 0 |
| K093731 | Vpap Iii ST-a | 2010 | 0 |
| K090804 | Nasal Aire II Pediatric, Model 5 Sizes, Model TBD | 2009 | 0 |
Has anything in its family been recalled? (10 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.
- K090539Bipap Autosv AdvancedRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 12 Class I recalls
- K090248Bipap AutosvRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations on · ◆ in the 2009 descendants bar of FIG. 14 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 13 Class I recalls
- K122715Stellar 150Resmed Germany, Inc. · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K111378Oximetry Interface KitPhilips Respironics, Inc. · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
Nearest 5 of 10; all are on the web page.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 7.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K063533 (Respironics, Inc., 2007) has gone furthest, with 30 descendants of its own.
- 4 other devices also cite its predicate K033276.
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.
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 VPAP III ST-A/Kidsta Mask system is intended to provide non-invasive ventilation for pediatric patients aged 7 years or older (>40lbs) with respiratory insufficiency or obstructive sleep apnea (GSA). The device is intended for use in the hospital or home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060105 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060105: Vpap Iii ST-a/Kidsta Mask System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060105
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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