510(k) · Cleared
Recalled · Class I · 2024Vivo 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 27, 2021 as substantially equivalent to K160481 (Breas Medical AB, 2016) and 1 other predicate after a 401-day review. Its family tree reaches back 13 generations to 1996. 18 of the 177 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- Jan 27, 2021
- Review
- 401 days
- Class
- Class II
- Product code
- NOU
- Recalls
- 3 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 13 generations to K953930 (1996). 174 ancestors in all, the oldest K811102 (1981). 2 later devices descend from it, 2 citing it directly. 18 of the 177 devices in this family, counting this one, have a Class I recall.
- Root · 13 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 9 generations between
- 3 generations backK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 2 generations backK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 1 generation backK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- This deviceK193586 Vivo 45 LSBreas Medical AB · 2021
- Descendant · cites it directly · 0 of its ownK232365 Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK233452 Vivo 45 LSBreas Medical AB · 2025 · Recalled
Show all 13 generations
- Root · 13 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 12 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 11 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 10 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 9 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 8 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 7 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 6 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 5 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 4 generations backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- 3 generations backK113053 Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 2 generations backK121623 Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · Recalled (Class I)
- 1 generation backK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- This deviceK193586 Vivo 45 LSBreas Medical AB · 2021
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −12 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −11 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −10 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −9 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −8 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −7 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −6 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −5 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −4 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| −3 | K113053 | Bipap a 30 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| −2 | K121623 | Bipap a 40 Ventilatory Support System | Respironics, Inc. | 2012 | Class I |
| −1 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| 0 (this device) | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | — |
| +1 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | — |
| +1 | K233452 | Vivo 45 LS | Breas Medical AB | 2025 | 1 |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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.
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 K233452 Vivo 45 LSscore 10.6 · 14 generations · no Class I recall
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 |
|---|---|---|---|
| * | K160481 | Vivo 60Summary page 4…Class: Class II Predicate Device (Primary): Device: Vivo 60 510(k) Number: K160481 Manufacturer: Breas Medical Predicate Device (Secondary): Device:… | 2016 |
| * | K181166 | Trilogy EvoSummary page 4…turer: Breas Medical Predicate Device (Secondary): Device: Trilogy Evo 510(k) Number: K181166 Manufacturer: Respironics Intended Use: To provide continuous or intermi… | 2019 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (18 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 25, 2024 | Class I | Z-2690-2024 | Under Investigation by firm | There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions. |
| 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 |
| Jun 2, 2022 | Class II | Z-1382-2022 | Device Design | A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be… |
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.
- K181166Trilogy EvoRespironics, Inc. · 2019 · Direct predicate · ◆ on the line of descent in FIG. 131 Class I recalls
- K162877VOCSN Unified Respiratory SystemVentec Life Systems, Inc. · 2017 · 2 generations back · ◆ in the 2017 ancestors bar of FIG. 114 Class I recalls
- K121623Bipap a 40 Ventilatory Support SystemRespironics, Inc. · 2012 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K111610Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · 2 generations back · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
- K113053Bipap a 30 Ventilatory Support SystemRespironics, Inc. · 2012 · 3 generations back · ◆ on the line of descent in FIG. 15 Class I recalls
- K093905Trilogy 202 VentilatorRespironics, Inc. · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 12 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K083526Trilogy 100 VentilatorRespironics Inc., Sleep & Home Respiratory Group · 2009 · 3 generations back · ◆ in the 2009 ancestors bar of FIG. 15 Class I recalls
- K070594Palmtop Ventilator, Models PTV-8, PTV-10Pulmonetic Systems, Inc. · 2007 · 3 generations back · ◆ in the 2007 ancestors bar of FIG. 12 Class I recalls
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K082660V60 Ventilator, Model V8000Respironics California, Inc. · 2009 · 4 generations back · ◆ in the 2009 ancestors bar of FIG. 13 Class I recalls
- K001646Puritan-Bennett 840 Ventilator System with Neomode OptionPuritan Bennett Corp. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
Nearest 12 of 17 shown.
Nearest 5 of 17; all are on the web page.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 57 of the 174 ancestors have a recall of any class; 17 have a Class I recall.
- Of its descendants, K232365 (Oconnell Regulatory Consultants, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K160481.
How does its category compare?
All NOU devicesNOU Continuous, Ventilator, Home Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 C02 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 lbs.), 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 C02 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 lbs.), 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 C02 sensor is intended to measure C02 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 as stated in the FDA summary.
https://510kreport.com/device/K193586 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193586: Vivo 45 LS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193586
Report an extraction error
Are you the manufacturer?
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