510(k) · Cleared
ClearedCardioVision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icardio.Ai · QUO Adjunctive Heart Failure Status Indicator
Cleared on Nov 21, 2025 as substantially equivalent to K222463 (Ultromics Limited, 2022) after a 210-day review. Its family tree reaches back 14 generations to 1997.
- Decided
- Nov 21, 2025
- Review
- 210 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 deviceK251293 CardioVisionIcardio.Ai · 2025
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 deviceK251293 CardioVisionIcardio.Ai · 2025
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) | K251293 | CardioVision | Icardio.Ai | 2025 | — |
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 5…Status Indicator Device Class: Class II Product Code: QUO 510(k) Number: K222463 510(k) Clearance Date: November 23, 2022 iCardio.ai 510(K) Summary - Page 1 of 10… | 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 28 years and passes through 9 companies; a new generation was cleared every 1.7 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. 2025, 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 iCardio.ai CardioVision™ AI is an automated machine learning–based decision support system, indicated as a diagnostic aid for patients undergoing an echocardiographic exam consisting of a single PLAX view in an outpatient environment, such as a primary care setting. When utilized by an interpreting clinician, this device provides information that may be useful in detecting moderate or severe aortic stenosis. iCardio.ai CardioVision™ AI is indicated…
Read the full statement (104 words)
The iCardio.ai CardioVision™ AI is an automated machine learning–based decision support system, indicated as a diagnostic aid for patients undergoing an echocardiographic exam consisting of a single PLAX view in an outpatient environment, such as a primary care setting.
When utilized by an interpreting clinician, this device provides information that may be useful in detecting moderate or severe aortic stenosis. iCardio.ai CardioVision™ AI is indicated in adult populations over 21 years of age. Patient management decisions should not be made solely on the results of the iCardio.ai CardioVision™ AI analysis. iCardio.ai CardioVision™ AI analyzes a single cine-loop DICOM of the parasternal long axis (PLAX).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251293 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251293: CardioVision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251293
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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