510(k) · Cleared
ClearedStellar 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 Apr 5, 2012 as substantially equivalent to K103167 (Resmed Germany, Inc., 2011) after a 118-day review. Its family tree reaches back 9 generations to 1991. 4 of the 81 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Apr 5, 2012
- Review
- 118 days
- Class
- Class II
- Product code
- MNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K902859 (1991). 79 ancestors in all, the oldest K883038 (1988). 1 later device descends from it, 1 citing it directly. 4 of the 81 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 5 generations between
- 3 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 2 generations backK060705 Carina HomeDraeger Medical B.V. · 2006 · Recalled
- 1 generation backK103167 Stellar 150Resmed Germany, Inc. · 2011
- This deviceK113640 Stellar 150Resmed Germany, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK122715 Stellar 150Resmed Germany, Inc. · 2013 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 8 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 7 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 6 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 5 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 4 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 3 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 2 generations backK060705 Carina HomeDraeger Medical B.V. · 2006 · Recalled
- 1 generation backK103167 Stellar 150Resmed Germany, Inc. · 2011
- This deviceK113640 Stellar 150Resmed Germany, Inc. · 2012
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K122715Stellar 150Resmed Germany, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −8 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −7 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −6 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −5 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −4 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −3 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −2 | K060705 | Carina Home | Draeger Medical B.V. | 2006 | 1 |
| −1 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| 0 (this device) | K113640 | Stellar 150 | Resmed Germany, Inc. | 2012 | — |
| +1 | K122715 | Stellar 150 | Resmed Germany, Inc. | 2013 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 3 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 10 | 2 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 10 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 1 |
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.
4 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? (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 |
|---|---|---|---|
| * | K103167 | Stellar 150Summary page 1…e MNT Ventilator, continuous, minimal ventilatory support. facility use Predicate Device STELLAR 150 (K103167) Reason for submission Change of Indication for Use December 7,2011 C89440… | 2011 |
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 |
|---|---|---|---|
| K122715 | Stellar 150 Class I | 2013 | 0 |
Has anything in its family been recalled? (4 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 · 5 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K981072Esprit VentilatorRespironics, Inc. · 1998 · 5 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 · 6 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K122715Stellar 150Resmed Germany, Inc. · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- 19 of the 79 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K122715 (Resmed Germany, Inc., 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103167.
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. 2012, 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 as stated in the FDA summary.
https://510kreport.com/device/K113640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113640: 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/K113640
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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