510(k) · Cleared
Recalled · Class II · 2023Vivo 45 LS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Breas Medical AB · NOU Continuous, Ventilator, Home Use
Cleared on Jan 13, 2025 as substantially equivalent to K193586 (Breas Medical AB, 2021) after a 451-day review. Its family tree reaches back 14 generations to 1996. 18 of the 176 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Jan 13, 2025
- Review
- 451 days
- Class
- Class II
- Product code
- NOU
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 14 generations to K953930 (1996). 175 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet. 18 of the 176 devices in this family, counting this one, have a Class I recall.
- Root · 14 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 10 generations between
- 3 generations backK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 2 generations backK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- 1 generation backK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- This deviceK233452 Vivo 45 LSBreas Medical AB · 2025
Show all 14 generations
- Root · 14 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 13 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 12 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 11 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 10 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 9 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 8 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 7 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 6 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 5 generations backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- 4 generations backK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 3 generations backK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 2 generations backK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- 1 generation backK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- This deviceK233452 Vivo 45 LSBreas Medical AB · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −13 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −12 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −11 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −10 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −9 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −8 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −7 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −6 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −5 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| −4 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| −3 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| −2 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| −1 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| 0 (this device) | K233452 | Vivo 45 LS | Breas Medical AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 6 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 10 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 5 | 0 |
| 1998 | 17 | 2 |
| 1999 | 8 | 0 |
| 2000 | 8 | 1 |
| 2001 | 11 | 0 |
| 2002 | 10 | 1 |
| 2003 | 9 | 1 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 1 |
| 2008 | 4 | 0 |
| 2009 | 5 | 2 |
| 2010 | 3 | 2 |
| 2011 | 3 | 1 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 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.
18 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 NOU device
- #1 K193586 Vivo 45 LSscore -3.7 · 13 generations · Class I recall
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 |
|---|---|---|---|
| * | K193586 | Vivo 45 LSSummary page 5…home use Classification Name Continuous ventilators; 21 C.F.R. §868.5895 Class II Product Code: NOU Primary Predicate Device(s) Breas Medical AB Vivo 45 LS cleared in K193586 Reference Device(s) Fisher & Paykel Healthcare, LTD. MR810Respiratory Humidifier cleared in K131957 Newport Medical Instruments,… | 2021 |
| † | K131957 | MR810RESPIRATORY Humidifier, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual… | 2013 |
| † | K082724 | Newport HTS50 Ventilator with Dual Pac Battery System | 2008 |
| † | K131895 | Airvo 2 Humidifier, Myairvo 2 Humidifier | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (18 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 13, 2023 | Class II | Z-0405-2024 | Process control | Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation |
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.
- K193586Vivo 45 LSBreas Medical AB · 2021 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · 2 generations back · ◆ on the line of descent in FIG. 131 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 3 generations back · ◆ in the 2017 ancestors bar of FIG. 114 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 3 generations back · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 4 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K093905Trilogy 202 VentilatorRespironics, Inc. · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 4 generations back · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 4 generations back · ◆ in the 2009 ancestors bar of FIG. 15 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 4 generations back · ◆ in the 2007 ancestors bar of FIG. 12 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 5 generations back · ◆ in the 2009 ancestors bar of FIG. 13 Class I recalls
Nearest 12 of 18 shown.
Nearest 5 of 18; all are on the web page.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- 58 of the 175 ancestors have a recall of any class; 18 have a Class I recall.
- 1 other device also cites its predicate K193586.
How does its category compare?
All NOU devicesNOU Continuous, Ventilator, Home Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · NOU
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NOU
Too few NOU 510(k)s in any year since 2007 to give a median.
Recalls per year · NOU
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NOU
932in 2025
MAUDE reports naming product code NOU, 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 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 1,217 |
| 2016 | 1 | — | 0 | 1,160 |
| 2017 | 0 | — | 0 | 175 |
| 2018 | 0 | — | 0 | 41 |
| 2019 | 0 | — | 0 | 37 |
| 2020 | 0 | — | 0 | 67 |
| 2021 | 1 | — | 0 | 248 |
| 2022 | 0 | — | 0 | 336 |
| 2023 | 0 | — | 1 | 1,259 |
| 2024 | 0 | — | 0 | 817 |
| 2025 | 1 | — | 0 | 932 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The Vivo 45 LS ventilator (with or without the SpO2 and CO2 sensors) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 Ibs.), however, the mouthpiece ventilation modes are for adult patients only. The Vivo 45 LS with the SpO2 sensor is intended to measure functional…
Read the full statement (147 words)
The Vivo 45 LS ventilator (with or without the SpO2 and CO2 sensors) is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for pediatric through adult patients weighing more than 5 kg (11 Ibs.), however, the mouthpiece ventilation modes are for adult patients only.
The Vivo 45 LS with the SpO2 sensor is intended to measure functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate.
The Vivo 45 LS with the CO2 sensor is intended to measure CO2 in the inspiratory and expiratory gas.
The device is intended to be used in home, institution, hospitals and portable applications such as wheelchairs and gurneys. It may be used for both invasive and non-invasive ventilation. The Vivo 45 LS is not intended to be used as an emergency transport or critical care ventilator.
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/K233452 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233452: Vivo 45 LS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233452
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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