510(k) · Cleared
Recalled · Class II · 2020Vivo 60
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 Nov 9, 2016 as substantially equivalent to K123144 (Ge Healthcare, Breas Medical AB, 2013) and 1 other predicate after a 261-day review. Its family tree reaches back 11 generations to 1991. 11 of the 95 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 9, 2016
- Review
- 261 days
- Class
- Class II
- Product code
- NOU
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 11 generations to K902859 (1991). 87 ancestors in all, the oldest K841279 (1984). 7 later devices descend from it, 3 citing it directly. 11 of the 95 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 7 generations between
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- 1 generation backK123144 VIVO 50Ge Healthcare, Breas Medical AB · 2013 · Recalled
- This deviceK160481 Vivo 60Breas Medical AB · 2016
- Descendant · cites it directly · 5 of its ownK181166 Trilogy EvoRespironics, Inc. · 2019 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK193586 Vivo 45 LSBreas Medical AB · 2021 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK232365 Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233452 Vivo 45 LSBreas Medical AB · 2025 · Recalled
- Descendant · 2 generations on · 0 of its ownK241135 RESPOND (R) VentilatorCorvent Medical, Inc. · 2024
Show all 11 generations
- Root · 11 generations backK902859 Servo Ventilator 300Siemens Life Support Systems · 1991 · Recalled
- 10 generations backK960010 Servo Ventilator 300 Computer InterfaceSiemens Elema AB · 1996
- 9 generations backK970839 Servo Ventilator 300ASiemens Elema AB · 1997 · Recalled
- 8 generations backK992788 Bear Cub 750 PSVBear Medical Systems, Inc. · 1999
- 7 generations backK013642 AVEABird Products Corp. · 2002 · Recalled (Class I)
- 6 generations backK032451 Bird Tbird Vela VentilatorBird Products Corp. · 2004 · Recalled
- 5 generations backK052554 Modification to: Ivent 201 Portable VentilatorVersamed Medical Systems, Inc. · 2005
- 4 generations backK053270 IVENT 201Versamed Medical Systems, Inc. · 2006
- 3 generations backK061627 Modification to I Vent 201Versamed Medical Systems, Inc. · 2006
- 2 generations backK111610 Trilogy Series Ventilator with OximetryRespironics, Inc. · 2011 · Recalled (Class I)
- 1 generation backK123144 VIVO 50Ge Healthcare, Breas Medical AB · 2013 · Recalled
- This deviceK160481 Vivo 60Breas Medical AB · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K181166Trilogy EvoRespironics, Inc. · 2019 · cites it directly5descendants
- K193586Vivo 45 LSBreas Medical AB · 2021 · cites it directly2descendants
- K232365Vivo 45 LSOconnell Regulatory Consultants, Inc. · 2025 · 2 generations on0descendants
- K233452Vivo 45 LSBreas Medical AB · 2025 · 2 generations on0descendants
- K241135RESPOND (R) VentilatorCorvent Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K902859 | Servo Ventilator 300 | Siemens Life Support Systems | 1991 | 3 |
| −10 | K960010 | Servo Ventilator 300 Computer Interface | Siemens Elema AB | 1996 | — |
| −9 | K970839 | Servo Ventilator 300A | Siemens Elema AB | 1997 | 4 |
| −8 | K992788 | Bear Cub 750 PSV | Bear Medical Systems, Inc. | 1999 | — |
| −7 | K013642 | AVEA | Bird Products Corp. | 2002 | Class I |
| −6 | K032451 | Bird Tbird Vela Ventilator | Bird Products Corp. | 2004 | 1 |
| −5 | K052554 | Modification to: Ivent 201 Portable Ventilator | Versamed Medical Systems, Inc. | 2005 | — |
| −4 | K053270 | IVENT 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −3 | K061627 | Modification to I Vent 201 | Versamed Medical Systems, Inc. | 2006 | — |
| −2 | K111610 | Trilogy Series Ventilator with Oximetry | Respironics, Inc. | 2011 | Class I |
| −1 | K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013 | 1 |
| 0 (this device) | K160481 | Vivo 60 | Breas Medical AB | 2016 | — |
| +1 | K181166 | Trilogy Evo | Respironics, Inc. | 2019 | Class I |
| +1 | K193586 | Vivo 45 LS | Breas Medical AB | 2021 | Class I |
| +2 | K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | 2025 | — |
| +2 | K233452 | Vivo 45 LS | Breas Medical AB | 2025 | 1 |
| +2 | K241135 | RESPOND (R) Ventilator | Corvent Medical, Inc. | 2024 | — |
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 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 10 | 2 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 1 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 1 |
| 2010 | 2 | 2 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 2 |
| 2021 | 1 | 1 |
| 2024 | 2 | 0 |
| 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.
11 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
- #2 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 |
|---|---|---|---|
| * | K123144 | VIVO 50Summary page 4…21 C.F.R. §868.1400. Device Class: Class II Predicate Devices: Device: Vivo 50 510(k) Number: K123144 Manufacturer: Breas Medical Device: Astral 110/1… | 2013 |
| * | K133868 | Astral VentilatorSummary page 4…Manufacturer: Breas Medical Device: Astral 110/150 510(k) Number: K133868 Manufacturer: ResMed Corporation Intended Use: To provide continuous or inte… | 2014 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (11 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 28, 2020 | Class II | Z-1352-2020 | Device Design | The outlet hole of the exhalation valve control pressure tube on the ventilator may become obstructed by the protective cover. |
| May 8, 2018 | Class III | Z-2530-2018 | Employee error | Some Vivo 65 devices have an unreleased version of the Firmware upgrade tool. |
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 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K093416Trilogy 200 VentilatorRespironics, Inc. · 2010 · 2 generations back · ◆ in the 2010 ancestors bar of FIG. 14 Class I recalls
- K093905Trilogy 202 VentilatorRespironics, Inc. · 2010 · 3 generations back · ◆ in the 2010 ancestors bar of FIG. 12 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
- K013642AVEABird Products Corp. · 2002 · 4 generations back · ◆ on the line of descent in FIG. 113 Class I recalls
- K023366Datex-Ohmeda 7900 Ventilator EnhancementsDatex-Ohmeda, Inc. · 2003 · 5 generations back · ◆ in the 2003 ancestors bar of FIG. 11 Class I recall
- 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 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K181170Trilogy Evo UniversalRespironics, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 112 Class I recalls
- K193586Vivo 45 LSBreas Medical AB · 2021 · Cites it directly · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K181166Trilogy EvoRespironics, Inc. · 2019 · Cites it directly · ◆ in the 2019 descendants bar of FIG. 131 Class I recalls
Nearest 5 of 11; all are on the web page.
What does this lineage say?
- The line of descent spans 25 years and passes through 8 companies; a new generation was cleared every 1.8 years on median.
- 30 of the 87 ancestors have a recall of any class; 8 have a Class I recall.
- Of its descendants, K181166 (Respironics, Inc., 2019) has gone furthest, with 5 descendants of its own.
How does its category compare?
All NOU devicesNOU Continuous, Ventilator, Home Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 60 ventilator (with or without the iOxy and CO2 sensor) 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.) The Vivo 60 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. The Vivo 60 with the…
Read the full statement (130 words)
The Vivo 60 ventilator (with or without the iOxy and CO2 sensor) 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.)
The Vivo 60 with the iOxy is intended to measure functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate.
The Vivo 60 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 60 is not intended to be used as a transport or critical care ventilator.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160481 · printed Nov 3, 2026
Cite this page
510(k) Report. “K160481: Vivo 60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K160481
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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