510(k) · Cleared
ClearedMelys Atrial Fibrillation Screening Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Fluidics, LLC · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Mar 19, 2014 as substantially equivalent to K052767 (Lechnologies Research, Inc., 2006) after a 246-day review. Its family tree reaches back 3 generations to 1997. 7 later devices descend from it.
- Decided
- Mar 19, 2014
- Review
- 246 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963725 (1997). 7 ancestors in all, the oldest K920984 (1992). 7 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 2 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 1 generation backK052767 Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006
- This deviceK132206 Melys Atrial Fibrillation Screening MonitorAdvanced Fluidics, LLC · 2014
- Descendant · cites it directly · 6 of its ownK173872 FibriCheckQompium NV · 2018
- Descendant · 2 generations on · 2 of its ownK192415 Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC · 2020
- Descendant · 2 generations on · 1 of its ownK232804 FibriCheckQompium NV · 2024
- Descendant · 3 generations on · 0 of its ownK250233 PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.) · 2026
- Descendant · 3 generations on · 0 of its ownK213357 Study Watch with Irregular Pulse Monitor (Home), Study Watch with…Verily Life Sciences, LLC · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K173872FibriCheckQompium NV · 2018 · cites it directly6descendants
- K192415Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC · 2020 · 2 generations on2descendants
- K232804FibriCheckQompium NV · 2024 · 2 generations on1descendant
- K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.) · 2026 · 3 generations on0descendants
- K213357Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse MonitorVerily Life Sciences, LLC · 2022 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −2 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −1 | K052767 | Afibalert Atrial Fibrillation Detector | Lechnologies Research, Inc. | 2006 | — |
| 0 (this device) | K132206 | Melys Atrial Fibrillation Screening Monitor | Advanced Fluidics, LLC | 2014 | — |
| +1 | K173872 | FibriCheck | Qompium NV | 2018 | — |
| +2 | K192415 | Study Watch with Irregular Pulse Monitor | Verily Life Sciences, LLC | 2020 | — |
| +2 | K232804 | FibriCheck | Qompium NV | 2024 | — |
| +3 | K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | 2026 | — |
| +3 | K213357 | Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular… | Verily Life Sciences, LLC | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 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 |
|---|---|---|---|
| * | K052767 | Afibalert Atrial Fibrillation DetectorSummary page 1…807.92(a)(3) Legally Marketed Equivalent Device F- K Number IDevice Manufacturer K052767 AfibAlert Atrial Fibrillation Lechnologies Research, LLC Detector… | 2006 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173872 | FibriCheck | 2018 | 6 |
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 17 years and passes through 4 companies; a new generation was cleared every 4.8 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K173872 (Qompium NV, 2018) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K052767.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Melys Atrial Fibrillation Monitor is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132206 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132206: Melys Atrial Fibrillation Screening Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132206
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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