510(k) · Cleared
Recalled · Class I · 2019Stellar 150
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Resmed Germany, Inc. · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on Jun 17, 2013 as substantially equivalent to K113640 (Resmed Germany, Inc., 2012) and 1 other predicate after a 285-day review. Its family tree reaches back 10 generations to 1991. 9 of the 104 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Jun 17, 2013
- Review
- 285 days
- Class
- Class II
- Product code
- MNT
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 10 generations to K902859 (1991). 103 ancestors in all, the oldest K841279 (1984). No later device cites it as a predicate yet. 9 of the 104 devices in this family, counting this one, have a Class I recall.
- Root · 10 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 6 generations between
- 3 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK122715 Stellar 150Resmed Germany, Inc. · 2013
Show all 10 generations
- Root · 10 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 9 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 8 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 7 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 6 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 5 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 4 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 3 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 1 generation backK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK122715 Stellar 150Resmed Germany, Inc. · 2013
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −9 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −8 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −7 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −6 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −5 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −4 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −3 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −2 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −1 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | Class I |
| 0 (this device) | K122715 | Stellar 150 | Resmed Germany, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 7 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 13 | 2 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 10 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 1 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2010 | 2 | 2 |
| 2011 | 1 | 0 |
| 2012 | 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.
9 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 MNT device
- #1 K233643 F&P Airvo 3 NIV (PT311US)score 13.5 · 10 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 |
|---|---|---|---|
| * | K113640 | Stellar 150Summary page 1…ax: +1858-836-5522 Stellar 150 Continuous ventilator 21 CFR 868.5895 - Product code MNT Ventilator, continuous, minimal ventilatory support, facility use Stellar 150 (K113640) Respironics Trilogy series Remote Alarm (K111610) New Remote Alarm accessory August 31, 2012 Stellar 150 510[k] Page 24 ===… | 2012 |
| * | K111610 | Trilogy Series Ventilator with OximetrySummary page 1…tor 21 CFR 868.5895 - Product code MNT Ventilator, continuous, minimal ventilatory support, facility use Stellar 150 (K113640) Respironics Trilogy series Remote Alarm (K111610) New Remote Alarm accessory August 31, 2012 Stellar 150 510[k] Page 24 RESMED Stellar 150 Traditional 510(k) P… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (9 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 12, 2019 | Class I | Z-0915-2020 | Device Design | Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more… |
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.
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K093905Trilogy 202 VentilatorRespironics, Inc. · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations back · ◆ in the 2009 ancestors bar of FIG. 15 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- K013642AVEABird Products Corp. · 2002 · 5 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K970460Nellcor Puritan Bennett, 840 Ventilator System (Model 840)Puritan Bennett Corp. · 1998 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 8; all are on the web page.
What does this lineage say?
- The line of descent spans 22 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 31 of the 103 ancestors have a recall of any class; 8 have a Class I recall.
How does its category compare?
All MNT devicesMNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MNT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNT
Too few MNT 510(k)s in any year since 2007 to give a median.
Recalls per year · MNT
5in 2022
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · MNT
3,545in 2025
MAUDE reports naming product code MNT, 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 | 0 | — | 1 | 59 |
| 2008 | 1 | — | 0 | 76 |
| 2009 | 2 | — | 1 | 29 |
| 2010 | 0 | — | 1 | 63 |
| 2011 | 2 | — | 0 | 170 |
| 2012 | 2 | — | 0 | 257 |
| 2013 | 1 | — | 0 | 322 |
| 2014 | 0 | — | 0 | 887 |
| 2015 | 0 | — | 0 | 1,657 |
| 2016 | 0 | — | 0 | 2,515 |
| 2017 | 1 | — | 0 | 2,878 |
| 2018 | 0 | — | 0 | 2,203 |
| 2019 | 0 | — | 1 (1) | 9,350 |
| 2020 | 1 | — | 33 | 4,170 |
| 2021 | 0 | — | 0 | 3,790 |
| 2022 | 1 | — | 5 (5) | 3,277 |
| 2023 | 1 | — | 0 | 4,565 |
| 2024 | 2 | — | 0 | 4,808 |
| 2025 | 1 | — | 0 | 3,545 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The device is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (30 lb / 13 kg and above) with respiratory insufficiency or respiratory failure, with or without obstructive sleep apnea. The device is for non-invasive use, or invasive use (with the use of the ResMed Leak Valve). Operation of the device includes both stationary, such as in hospital or home, or mobile, such as wheelchair usage.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122715: Stellar 150.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122715
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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