510(k) · Cleared
ClearedVivio® LVEDP System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Avicena, LLC · QUO Adjunctive Heart Failure Status Indicator
Cleared on Oct 6, 2023 as substantially equivalent to K222463 (Ultromics Limited, 2022) after a 282-day review. Its family tree reaches back 14 generations to 1997.
- Decided
- Oct 6, 2023
- Review
- 282 days
- Class
- Class II
- Product code
- QUO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K962603 (1997). 58 ancestors in all, the oldest K891104 (1989). No later device cites it as a predicate yet.
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 10 generations between
- 3 generations backK202306 T3 Platform softwareEtiometry, Inc. · 2020
- 2 generations backK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- 1 generation backK222463 EchoGo Heart FailureUltromics Limited · 2022
- This deviceK223905 Vivio® LVEDP SystemAvicena, LLC · 2023
Show all 14 generations
- Root · 14 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 13 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 12 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 11 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 10 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 9 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 8 generations backK081140 VisensiaObs Medical · 2008
- 7 generations backK110953 Visensia, Visensia with AlertObs Medical · 2011
- 6 generations backK152258 T3 SoftwareEtiometry, Inc. · 2016
- 5 generations backK163065 T3 SoftwareEtiometry, Inc. · 2017
- 4 generations backK190273 T3 Platform softwareEtiometry, Inc. · 2019
- 3 generations backK202306 T3 Platform softwareEtiometry, Inc. · 2020
- 2 generations backK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- 1 generation backK222463 EchoGo Heart FailureUltromics Limited · 2022
- This deviceK223905 Vivio® LVEDP SystemAvicena, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −13 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −12 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −11 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −10 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −9 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −8 | K081140 | Visensia | Obs Medical | 2008 | — |
| −7 | K110953 | Visensia, Visensia with Alert | Obs Medical | 2011 | — |
| −6 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| −5 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
| −4 | K190273 | T3 Platform software | Etiometry, Inc. | 2019 | — |
| −3 | K202306 | T3 Platform software | Etiometry, Inc. | 2020 | — |
| −2 | K213230 | T3 Platform Software | Etiometry, Inc. | 2022 | — |
| −1 | K222463 | EchoGo Heart Failure | Ultromics Limited | 2022 | — |
| 0 (this device) | K223905 | Vivio® LVEDP System | Avicena, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 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.
Planning a device in QUO? 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 QUO device
- #1 K222463 EchoGo Heart Failurescore 23.0 · 13 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 |
|---|---|---|---|
| * | K222463 | EchoGo Heart FailureSummary page 4…djunctive cardiovascular status indicator Regulation No.: 870.2200 Classification Code: QUO Predicate Device: EchoGo Heart Failure: 510(k) Number K222463 Classification Code: QUO Regulation: 870.2200 Device Description 807.… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 9 companies; a new generation was cleared every 1.6 years on median.
- 7 of the 58 ancestors have a recall of any class.
- 4 other devices also cite its predicate K222463.
How does its category compare?
All QUO devicesQUO Adjunctive Heart Failure Status Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QUO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QUO
Too few QUO 510(k)s in any year since 2007 to give a median.
Recalls per year · QUO
No recall names QUO since 2007.
Adverse event reports per year · QUO
No MAUDE report names QUO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vivio® System is indicated to non-invasively estimate left ventricular end-diastolic pressure (LVEDP) is above or below 18mmHg. This measurement can aid in the diagnosis of heart failure when used by qualified healthcare professionals as an adjunct alongside other clinically relevant information. For use in adults only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223905 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223905: Vivio® LVEDP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223905
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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