510(k) · Cleared
ClearedBreas Vivo 40 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Breas Medical AB · MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Cleared on May 14, 2009 as substantially equivalent to K071702 (Breas Medical AB, 2008) and 1 other predicate after a 113-day review. Its family tree reaches back 5 generations to 1997. 5 of the 42 devices in its family, counting itself, have a Class I recall. 23 later devices descend from it.
- Decided
- May 14, 2009
- Review
- 113 days
- Class
- Class II
- Product code
- MNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971260 (1997). 18 ancestors in all, the oldest K961783 (1996). 23 later devices descend from it, 2 citing it directly. 5 of the 42 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK971260 Sullivan Humidaire Heated HumidifierResmed Corp · 1997
- 4 generations backK013909 S7 Elite CP AP SystemResmed Corp · 2002
- 3 generations backK030843 Vpap IiiResmed, Ltd. · 2003
- 2 generations backK053607 Breas Vivo 40 SystemBreas Medical AB · 2006
- 1 generation backK071702 Breas Vivo Bilevel System, Model Vivo 40Breas Medical AB · 2008
- This deviceK090113 Breas Vivo 40 SystemBreas Medical AB · 2009
- Descendant · cites it directly · 20 of its ownK103167 Stellar 150Resmed Germany, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 7 of its ownK113288 Vpap ST-aResmed, Ltd. · 2012
- Descendant · 3 generations on · 6 of its ownK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- Descendant · 4 generations on · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 23 · See all- K103167Stellar 150Resmed Germany, Inc. · 2011 · cites it directly20descendants
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on8descendants
- K113288Vpap ST-aResmed, Ltd. · 2012 · 2 generations on7descendants
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations on6descendants
- K181166Trilogy EvoRespironics, Inc. · 2019 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971260 | Sullivan Humidaire Heated Humidifier | Resmed Corp | 1997 | — |
| −4 | K013909 | S7 Elite CP AP System | Resmed Corp | 2002 | — |
| −3 | K030843 | Vpap Iii | Resmed, Ltd. | 2003 | — |
| −2 | K053607 | Breas Vivo 40 System | Breas Medical AB | 2006 | — |
| −1 | K071702 | Breas Vivo Bilevel System, Model Vivo 40 | Breas Medical AB | 2008 | — |
| 0 (this device) | K090113 | Breas Vivo 40 System | Breas Medical AB | 2009 | — |
| +1 | K103167 | Stellar 150 | Resmed Germany, Inc. | 2011 | — |
| +2 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +2 | K113288 | Vpap ST-a | Resmed, Ltd. | 2012 | — |
| +3 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| +4 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 5 | 2 |
| 2013 | 2 | 1 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 1 |
| 2021 | 1 | 1 |
| 2022 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 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.
5 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 |
|---|---|---|---|
| * | K071702 | Breas Vivo Bilevel System, Model Vivo 40Summary page 1…ilator (21 CFR 868.5895) Product Code MNT': MNT Predicate Devices Breas Vivo 40 (curreft device (K07 1702) R'espironics BiPAPi.AVAPS (0,070328)… | 2008 |
| * | K070328 | Bipap Synchrony with AvapsSummary page 1…MNT Predicate Devices Breas Vivo 40 (curreft device (K07 1702) R'espironics BiPAPi.AVAPS (0,070328) Page 5.1 510(k) Premarket N… | 2007 |
What descends from it? (23)
See all 232 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 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.
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 15 Class I recalls
- 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
- 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
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K103167 (Resmed Germany, Inc., 2011) has gone furthest, with 20 descendants of its own.
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. 2009, 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 Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients >66 lbs (>30 kg) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea.
The Vivo 40 is not intended to provide the total ventilatory requirements of the patient.
The Vivo 40 is intended to be used for both invasive and non-invasive applications.
The Vivo 40 is intended to be operated by qualified and trained personnel.
The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments.
The Vivo 40 must always be prescribed by a licensed physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090113 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090113: Breas Vivo 40 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090113
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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