510(k) · Cleared
ClearedUs2.ca
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eko.Ai Pte Ltd. D/B/A Us2.Ai · SDJ Adjunctive Cardiac Amyloidosis Status Indicator
Cleared on Jun 20, 2025 as substantially equivalent to K240860 (Ultromics Limited, 2024) after a 150-day review. Its family tree reaches back 15 generations to 1997.
- Decided
- Jun 20, 2025
- Review
- 150 days
- Class
- Class II
- Product code
- SDJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K962603 (1997). 59 ancestors in all, the oldest K891104 (1989). No later device cites it as a predicate yet.
- Root · 15 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 11 generations between
- 3 generations backK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- 2 generations backK222463 EchoGo Heart FailureUltromics Limited · 2022
- 1 generation backK240860 EchoGo Amyloidosis (1.0)Ultromics Limited · 2024
- This deviceK250151 Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai · 2025
Show all 15 generations
- Root · 15 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 14 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 13 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 12 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 11 generations backK012451 Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246Welch Allyn Protocol, Inc. · 2001
- 10 generations backK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- 9 generations backK081140 VisensiaObs Medical · 2008
- 8 generations backK110953 Visensia, Visensia with AlertObs Medical · 2011
- 7 generations backK152258 T3 SoftwareEtiometry, Inc. · 2016
- 6 generations backK163065 T3 SoftwareEtiometry, Inc. · 2017
- 5 generations backK190273 T3 Platform softwareEtiometry, Inc. · 2019
- 4 generations backK202306 T3 Platform softwareEtiometry, Inc. · 2020
- 3 generations backK213230 T3 Platform SoftwareEtiometry, Inc. · 2022
- 2 generations backK222463 EchoGo Heart FailureUltromics Limited · 2022
- 1 generation backK240860 EchoGo Amyloidosis (1.0)Ultromics Limited · 2024
- This deviceK250151 Us2.caEko.Ai Pte Ltd. D/B/A Us2.Ai · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −14 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −13 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −12 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −11 | K012451 | Propaq Encore Models 202, 204, 206; Propaq CS Models 242, 244, 246 | Welch Allyn Protocol, Inc. | 2001 | — |
| −10 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| −9 | K081140 | Visensia | Obs Medical | 2008 | — |
| −8 | K110953 | Visensia, Visensia with Alert | Obs Medical | 2011 | — |
| −7 | K152258 | T3 Software | Etiometry, Inc. | 2016 | — |
| −6 | K163065 | T3 Software | Etiometry, Inc. | 2017 | — |
| −5 | K190273 | T3 Platform software | Etiometry, Inc. | 2019 | — |
| −4 | K202306 | T3 Platform software | Etiometry, Inc. | 2020 | — |
| −3 | K213230 | T3 Platform Software | Etiometry, Inc. | 2022 | — |
| −2 | K222463 | EchoGo Heart Failure | Ultromics Limited | 2022 | — |
| −1 | K240860 | EchoGo Amyloidosis (1.0) | Ultromics Limited | 2024 | — |
| 0 (this device) | K250151 | Us2.ca | Eko.Ai Pte Ltd. D/B/A Us2.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 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 K240860 EchoGo Amyloidosis (1.0)score 18.2 · 14 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 |
|---|---|---|---|
| * | K240860 | EchoGo Amyloidosis (1.0)Summary page 5…ue Indiator Device Class: Class II Product Code: SDJ 510(k) Number: K240860 510(k) Clearance Date: Nov 15, 2024… | 2024 |
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 1.6 years on median.
- 7 of the 59 ancestors have a recall of any class.
- 1 other device also cites its predicate K240860.
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. 2025, 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?
Us2.ca processes acquired transthoracic cardiac ultrasound images to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners in their diagnosis of cardiac amyloidosis. Us2.ca is intended for use only in adult patients with increased left ventricular wall thickness, defined as an interventricular septal thickness (IVSd) or left ventricular posterior wall thickness (LVPWd) > 12mm. Us2.ca is not intended to provide a diagnosis and does not replace current standards of care. The results from Us2.ca are not intended to exclude the need for further follow-up on cardiac amyloidosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250151: Us2.ca.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250151
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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