510(k) · Cleared
ClearedEchoGo Amyloidosis (1.0)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultromics Limited · SDJ Adjunctive Cardiac Amyloidosis Status Indicator
Cleared on Nov 15, 2024 as substantially equivalent to K222463 (Ultromics Limited, 2022) after a 232-day review. Its family tree reaches back 14 generations to 1997. 2 later devices descend from it.
- Decided
- Nov 15, 2024
- Review
- 232 days
- Class
- Class II
- Product code
- SDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K962603 (1997). 58 ancestors in all, the oldest K891104 (1989). 2 later devices descend from it, 2 citing it directly.
- 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 deviceK240860 EchoGo Amyloidosis (1.0)Ultromics Limited · 2024
- Descendant · cites it directly · 0 of its ownK250151 Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai · 2025
- Descendant · cites it directly · 0 of its ownK243866 InVision Precision Cardiac AmyloidInVision Medical Technology Corporation · 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 deviceK240860 EchoGo Amyloidosis (1.0)Ultromics Limited · 2024
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 |
|---|---|---|---|---|---|
| −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) | K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | 2024 | — |
| +1 | K250151 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.Ai | 2025 | — |
| +1 | K243866 | InVision Precision Cardiac Amyloid | InVision Medical Technology Corporation | 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 |
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.
Planning a device in SDJ? 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 SDJ device
- #1 K250151 Us2.cascore 13.7 · 15 generations · no Class I recall
- #2 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…choGo Amyloidosis 1.0. 3 Predicate Device Predicate Device EchoGo Heart Failure 510(k) K222463 Manufacturer Ultromics Limited EchoGo Amyloidosis 1.0 510(K) SUMM… | 2022 |
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? (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 27 years and passes through 8 companies; a new generation was cleared every 1.7 years on median.
- 7 of the 58 ancestors have a recall of any class.
- Of its descendants, K250151 (Eko.Ai Pte Ltd. D/B/A Us2.Ai, 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K222463.
How does its category compare?
All SDJ devicesSDJ Adjunctive Cardiac Amyloidosis Status Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SDJ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SDJ
Too few SDJ 510(k)s in any year since 2007 to give a median.
Recalls per year · SDJ
No recall names SDJ since 2007.
Adverse event reports per year · SDJ
No MAUDE report names SDJ 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 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
EchoGo Amyloidosis 1.0 is an automated machine learning-based decision support system,
indicated as a screening tool for adult patients aged 65 years and over with heart failure undergoing
cardiovascular assessment using echocardiography.
When utilised by an interpreting physician, this device provides information alerting the physician for
referral to confirmatory investigations.
EchoGo Amyloidosis 1.0 is indicated in adult patients aged 65 years and over with heart failure.
Patient management decisions should not be made solely on the results of the EchoGo Amyloidosis
1.0 analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240860 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240860: EchoGo Amyloidosis (1.0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240860
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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