510(k) · Cleared
ClearedAfibalert Atrial Fibrillation Detector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lechnologies Research, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Jun 23, 2006 as substantially equivalent to K020825 (Card Guard Scientific Survival, Ltd., 2002) and 2 other predicates after a 266-day review. Its family tree reaches back 2 generations to 1997. 47 later devices descend from it.
- Decided
- Jun 23, 2006
- Review
- 266 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K963725 (1997). 6 ancestors in all, the oldest K920984 (1992). 47 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 1 generation backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- This deviceK052767 Afibalert Atrial Fibrillation DetectorLechnologies Research, Inc. · 2006
- Descendant · cites it directly · 28 of its ownK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 19 of its ownK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- Descendant · 3 generations on · 12 of its ownK171816 Kardia Band SystemAliveCor, Inc. · 2017
- Descendant · cites it directly · 12 of its ownK080337 Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model…Microlife Corp. · 2008
- Descendant · cites it directly · 7 of its ownK132206 Melys Atrial Fibrillation Screening MonitorAdvanced Fluidics, LLC · 2014
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K140933Alivecor Heart MonitorAliveCor, Inc. · 2014 · cites it directly28descendants
- K142743AliveCor Heart MonitorAliveCor, Inc. · 2015 · 2 generations on19descendants
- K171816Kardia Band SystemAliveCor, Inc. · 2017 · 3 generations on12descendants
- K080337Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2DMicrolife Corp. · 2008 · cites it directly12descendants
- K132206Melys Atrial Fibrillation Screening MonitorAdvanced Fluidics, LLC · 2014 · cites it directly7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −1 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| 0 (this device) | K052767 | Afibalert Atrial Fibrillation Detector | Lechnologies Research, Inc. | 2006 | — |
| +1 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| +2 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| +3 | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| +1 | K080337 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MQ1-2D | Microlife Corp. | 2008 | — |
| +1 | K132206 | Melys Atrial Fibrillation Screening Monitor | Advanced Fluidics, LLC | 2014 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K020825 | King of Hearts Express + AF MonitorSummary page 1…e: DX H Predicate The subject device is equivalent to the following devices: Device(s): * The King of Hearts Express AF (K020825), manufactured by Instromedix * The CG-221 I SelfCheck ECG Transmitter (KO 12223), manufactured by… | 2002 |
| * | K012223 | CG-2211 Selfcheck Ecg Transmitter | 2001 |
| * | K010945 | Heartcard, Model 5258Summary page 1…221 I SelfCheck ECG Transmitter (KO 12223), manufactured by Card Guard Scientific Survival Ltd. * The HeartCard (K01 0945), manufactured by Instromedix Device Description: The AfibAlertTM is a cardiac event recorder capable of storing five 4… | 2001 |
What descends from it? (47)
See all 473 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 9 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K140933 (AliveCor, Inc., 2014) has gone furthest, with 28 descendants of its own.
- 10 other devices also cite its predicate K020825.
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.
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 AfibAlertTM 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/K052767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052767: Afibalert Atrial Fibrillation Detector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052767
Report an extraction error
Are you the manufacturer?
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