510(k) · Cleared
ClearedS-Patch CardioAI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wellysis Corp. · DPS Electrocardiograph
Cleared on Sep 25, 2026 as substantially equivalent to K210822 (Medicalgorithmics S.A., 2022) after a 270-day review. Its family tree reaches back 14 generations to 1988.
- Decided
- Sep 25, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K882803 (1988). 57 ancestors in all, the oldest K881905 (1988). No later device cites it as a predicate yet.
- Root · 14 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 10 generations between
- 3 generations backK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
- 2 generations backK181502 Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018
- 1 generation backK210822 DeepRhythmAIMedicalgorithmics S.A. · 2022
- This deviceK254255 S-Patch CardioAIWellysis Corp. · 2026
Show all 14 generations
- Root · 14 generations backK882803 ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque STAdvanced Cardiovascular Systems, Inc. · 1988
- 13 generations backK012241 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2002
- 12 generations backK052240 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002Cardionet, Inc. · 2005
- 11 generations backK063222 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2006
- 10 generations backK072558 Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model…Cardionet, Inc. · 2007
- 9 generations backK083287 Avivo Mobile Patient Management SystemCorventis, Inc. · 2009
- 8 generations backK090696 Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 7 generations backK091971 Avivo Mobile Patient Management System, Nuvant Mobile Cardiac…Corventis, Inc. · 2009
- 6 generations backK111917 Nuvant, Mobile Cardiac TelemetryCorventis, Inc. · 2011
- 5 generations backK113372 Nuvant, Mobilc Cardiac TelemetryCorventis, Inc. · 2012
- 4 generations backK133701 Nuvant MCT SystemCorventis, Inc. · 2014
- 3 generations backK163512 Zio AT ECG Monitoring SystemiRhythm Technologies, Inc. · 2017 · Recalled
- 2 generations backK181502 Zio AT ECG Monitoring System, ZEUS SystemiRhythm Technologies, Inc. · 2018
- 1 generation backK210822 DeepRhythmAIMedicalgorithmics S.A. · 2022
- This deviceK254255 S-Patch CardioAIWellysis Corp. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K882803 | ET HI-Flow Soft Tip/ET HI-Flow/Enhanced Torque ST | Advanced Cardiovascular Systems, Inc. | 1988 | — |
| −13 | K012241 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1001 | Cardionet, Inc. | 2002 | — |
| −12 | K052240 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model 1002 | Cardionet, Inc. | 2005 | — |
| −11 | K063222 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1004 | Cardionet, Inc. | 2006 | — |
| −10 | K072558 | Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection, Model CN1005 | Cardionet, Inc. | 2007 | — |
| −9 | K083287 | Avivo Mobile Patient Management System | Corventis, Inc. | 2009 | — |
| −8 | K090696 | Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System | Corventis, Inc. | 2009 | — |
| −7 | K091971 | Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (MCT)… | Corventis, Inc. | 2009 | — |
| −6 | K111917 | Nuvant, Mobile Cardiac Telemetry | Corventis, Inc. | 2011 | — |
| −5 | K113372 | Nuvant, Mobilc Cardiac Telemetry | Corventis, Inc. | 2012 | — |
| −4 | K133701 | Nuvant MCT System | Corventis, Inc. | 2014 | — |
| −3 | K163512 | Zio AT ECG Monitoring System | iRhythm Technologies, Inc. | 2017 | 1 |
| −2 | K181502 | Zio AT ECG Monitoring System, ZEUS System | iRhythm Technologies, Inc. | 2018 | — |
| −1 | K210822 | DeepRhythmAI | Medicalgorithmics S.A. | 2022 | — |
| 0 (this device) | K254255 | S-Patch CardioAI | Wellysis Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1992 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 DPS? 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 DPS device
- #1 K212112 Cardiologs Holter Platformscore 18.6 · 5 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 |
|---|---|---|---|
| * | K210822 | DeepRhythmAISummary page 5…870.1425 DQK and DPS Class II Predicate Device: DeepRhythmAI, K210822 Device Description: S-Patch CardioAI is proprietary Software as a Medical Device (SaMD) intended for the automated processing… | 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 38 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 57 ancestors have a recall of any class.
- 2 other devices also cite its predicate K210822.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DPS
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DPS
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DPS
3in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DPS
55in 2025
MAUDE reports naming product code DPS, 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 | 11 | 87 | 2 | 9 |
| 2008 | 13 | 31 | 0 | 17 |
| 2009 | 14 | 84 | 1 | 14 |
| 2010 | 11 | 104 | 2 | 21 |
| 2011 | 22 | 154 | 1 | 121 |
| 2012 | 12 | 117 | 0 | 56 |
| 2013 | 10 | 134 | 0 | 15 |
| 2014 | 11 | 253 | 0 | 15 |
| 2015 | 8 | 178 | 0 | 30 |
| 2016 | 11 | 229 | 0 | 12 |
| 2017 | 9 | 177 | 0 | 15 |
| 2018 | 14 | 221 | 0 | 19 |
| 2019 | 3 | 178 | 9 | 27 |
| 2020 | 6 | 224 | 2 | 59 |
| 2021 | 5 | 135 | 1 | 24 |
| 2022 | 6 | 244 | 1 | 59 |
| 2023 | 10 | 236 | 3 | 54 |
| 2024 | 8 | 260 | 4 (1) | 64 |
| 2025 | 6 | 163 | 3 | 55 |
| 2026 | 6 | 258 | 4 | — |
What is it indicated for?
S-Patch CardioAI is a software application intended for the assessment of cardiac arrhythmias using ambulatory ECG data in adults. It is intended for use by a healthcare solution integrator to build web, mobile, or other types of applications that allow qualified healthcare professionals to review and confirm the analytic results. The product supports downloading and analyzing data recorded in compatible formats from FDA-cleared S-Patch Ex and S-Patch…
Read the full statement (197 words)
S-Patch CardioAI is a software application intended for the assessment of cardiac arrhythmias using ambulatory ECG data in adults.
It is intended for use by a healthcare solution integrator to build web, mobile, or other types of applications that allow qualified healthcare professionals to review and confirm the analytic results.
The product supports downloading and analyzing data recorded in compatible formats from FDA-cleared S-Patch Ex and S-Patch ExL devices when assessment of the rhythm is necessary.
S-Patch CardioAI can be electronically interfaced to perform analysis on data transferred from other computer-based ECG systems, such as an ECG management system.
S-Patch CardioAI is not intended for use in life-supporting or life-sustaining systems or ECG Alarm devices. The interpretation results generated by S-Patch CardioAI are not intended to be the sole means of diagnosis. Interpretation of the device output must be made by the clinician; the results are offered to physicians and clinicians on an advisory basis only, to be used in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
CAUTION - Federal (U.S.) law restricts this device to sale by or on the order of a licensed healthcare practitioner.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254255: S-Patch CardioAI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254255
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026