510(k) · Cleared
ClearedRhythmAnalytics
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofourmis Singapore Pte., Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Mar 7, 2019 as substantially equivalent to K170568 (Cardiologs Technologies, 2017) after a 191-day review. Its family tree reaches back 5 generations to 2000. 7 later devices descend from it.
- Decided
- Mar 7, 2019
- Review
- 191 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003621 (2000). 7 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK003621 ST/AR ST and Arrhythmia Software, Model Release D.0Agilent Technologies, Inc. · 2000
- 4 generations backK013717 Brentwood Real Time ST and Arrhythmia Analysis Software LibraryBrentwood Medical Technology Corp. · 2002
- 3 generations backK043380 Monebo Automatic Arrhythmia Detection Software Library, Version 1Monebo Technologies, Inc. · 2005
- 2 generations backK062282 Monebo Automated Ecg Analysis and Interpretation Software Library…Monebo Technologies, Inc. · 2007
- 1 generation backK170568 CardioLogs ECG Analysis PlatformCardiologs Technologies · 2017
- This deviceK182344 RhythmAnalyticsBiofourmis Singapore Pte., Ltd. · 2019
- Descendant · cites it directly · 6 of its ownK210822 DeepRhythmAIMedicalgorithmics S.A. · 2022
- Descendant · cites it directly · 3 of its ownK241197 DeepRhythmAIMedicalgorithmics S.A. · 2024
- Descendant · 2 generations on · 1 of its ownK250932 DeepRhythmAIMedicalgorithmics S.A. · 2025
- Descendant · 2 generations on · 0 of its ownK254255 S-Patch CardioAIWellysis Corp. · 2026
- Descendant · 3 generations on · 0 of its ownK253141 DeepRhythmAIMedicalgorithmics S.A. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K210822DeepRhythmAIMedicalgorithmics S.A. · 2022 · cites it directly6descendants
- K241197DeepRhythmAIMedicalgorithmics S.A. · 2024 · cites it directly3descendants
- K250932DeepRhythmAIMedicalgorithmics S.A. · 2025 · 2 generations on1descendant
- K254255S-Patch CardioAIWellysis Corp. · 2026 · 2 generations on0descendants
- K253141DeepRhythmAIMedicalgorithmics S.A. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0 | Agilent Technologies, Inc. | 2000 | — |
| −4 | K013717 | Brentwood Real Time ST and Arrhythmia Analysis Software Library | Brentwood Medical Technology Corp. | 2002 | — |
| −3 | K043380 | Monebo Automatic Arrhythmia Detection Software Library, Version 1 | Monebo Technologies, Inc. | 2005 | — |
| −2 | K062282 | Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0 | Monebo Technologies, Inc. | 2007 | — |
| −1 | K170568 | CardioLogs ECG Analysis Platform | Cardiologs Technologies | 2017 | — |
| 0 (this device) | K182344 | RhythmAnalytics | Biofourmis Singapore Pte., Ltd. | 2019 | — |
| +1 | K210822 | DeepRhythmAI | Medicalgorithmics S.A. | 2022 | — |
| +1 | K241197 | DeepRhythmAI | Medicalgorithmics S.A. | 2024 | — |
| +2 | K250932 | DeepRhythmAI | Medicalgorithmics S.A. | 2025 | — |
| +2 | K254255 | S-Patch CardioAI | Wellysis Corp. | 2026 | — |
| +3 | K253141 | DeepRhythmAI | Medicalgorithmics S.A. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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 |
|---|---|---|---|
| * | K170568 | CardioLogs ECG Analysis PlatformSummary page 4…DQK, 21 CFR 870.1425 DPS, 21 CFR 870.2340 Classification: Class II Predicate Device: • CardioLogs ECG Analysis Platform – K170568 Device Description: RhythmAnalytics consists of (1) A web application programming interface (API) which an authentic user to upl… | 2017 |
What descends from it? (7)
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 19 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K210822 (Medicalgorithmics S.A., 2022) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K170568.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
RhythmAnalytics is a software application for the assessment of cardiac arrhythmias using single-lead ECG data in subjects over 18 years of age. It is intended for use by a healthcare solution integrator to build web or mobile applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analysing data recorded in compatible formats from any FDA cleared device used for the arrhythmia…
Read the full statement (222 words)
RhythmAnalytics is a software application for the assessment of cardiac arrhythmias using single-lead ECG data in subjects over 18 years of age. It is intended for use by a healthcare solution integrator to build web or mobile applications to let qualified healthcare professionals review and confirm the analytic result. The product supports downloading and analysing data recorded in compatible formats from any FDA cleared device used for the arrhythmia diagnostics such as Holter, event recorder, or other similar devices when assessment of the rhythm is necessary. RhythmAnalytics can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. RhythmAnalytics provides ECG signal processing and analysis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis. RhythmAnalytics is not for use in life supporting or sustaining systems or ECG monitor and Alarm devices.
The product can be integrated into medical devices. In this case, the medical device manufacturer will identify the indication for use depending on the application of their device.
RhythmAnalytics interpretation results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
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/K182344 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182344: RhythmAnalytics.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182344
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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