510(k) · Cleared
ClearedZywieAI Software Library
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zywie, Inc. · DPS Electrocardiograph
Cleared on Feb 20, 2015 as substantially equivalent to K062282 (Monebo Technologies, Inc., 2007) and 1 other predicate after a 151-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Feb 20, 2015
- Review
- 151 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K871344 (1987). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK871344 Pathfinder 3, Auto Surveyor and SurveyorReynolds Medical, Ltd. · 1987
- 3 generations backK951902 Pathfinder 700 Holter AnalyzerReynolds Medical, Ltd. · 1996 · Recalled
- 2 generations backK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
- 1 generation backK031466 Iqmark Digital HolterBrentwood Medical Technology Corp. · 2003
- This deviceK142693 ZywieAI Software LibraryZywie, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871344 | Pathfinder 3, Auto Surveyor and Surveyor | Reynolds Medical, Ltd. | 1987 | — |
| −3 | K951902 | Pathfinder 700 Holter Analyzer | Reynolds Medical, Ltd. | 1996 | 1 |
| −2 | K990727 | Syneflash & Syneview | Ela Medical, Inc. | 1999 | — |
| −1 | K031466 | Iqmark Digital Holter | Brentwood Medical Technology Corp. | 2003 | — |
| 0 (this device) | K142693 | ZywieAI Software Library | Zywie, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 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? (2)
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 |
|---|---|---|---|
| * | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0Summary page 4…ubstantially equivalent in intended use and similar technological characteristics of Monebo Automatic ECG Analysis and Interpretation Software Library cleared as part of K062282 and the IQmark Digital Holter which was cleared under K031466. These predicates have not been subject to a design-related recall… | 2007 |
| * | K031466 | Iqmark Digital HolterSummary page 4…cal characteristics of Monebo Automatic ECG Analysis and Interpretation Software Library cleared as part of K062282 and the IQmark Digital Holter which was cleared under K031466. These predicates have not been subject to a design-related recall. No reference devices were used in this submission Page 1 of… | 2003 |
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 4 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 8 other devices also cite its predicate K062282.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The ZywieAl Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory ECG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, Event Monitor, MCT (Mobile Cardio Telemetry), or other similar devices when assessment of the rhythm is necessary. The ZywieAl Software Library can also…
Read the full statement (215 words)
The ZywieAl Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory ECG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, Event Monitor, MCT (Mobile Cardio Telemetry), or other similar devices when assessment of the rhythm is necessary. The ZywieAl Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as ECG management system. The software library provides ECG signal processing and analysis on a beat by beat basis, QRS Detection, Non-paced Arrhythmia Interpretation, PAC (Premature Atrial Contraction), Non-paced Heart Rate determination, Pause, Tachycardia, Bradycardia, Atrial Flutter/Fibrillation, Ventricular Flutter/Fibrillation, Ventricular Ectopic Beat detection, Ventricular Tachycardia, AV (Atrioventricular) Conduction Block, ST Change Episode detection, and Non-paced Ventricular Arrhythmia calls.
The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.
The product cannot be used with potentially life-threatening arrhythmias which require inpatient monitoring.
Verification of the output from ZywieAl Software is the responsibility of a trained healthcare professional or physician.
The ZywieAl Software Library is used for analyzing ECG data for adult patient population.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142693 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142693: ZywieAI Software Library.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142693
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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