510(k) · Cleared
ClearedB-Secur HeartKey Software Library
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B-Secur, Ltd. · DPS Electrocardiograph
Cleared on Dec 7, 2020 as substantially equivalent to K181823 (AliveCor, Inc., 2019) after a 249-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Dec 7, 2020
- Review
- 249 days
- Class
- Class II
- Product code
- DPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K963725 (1997). 20 ancestors in all, the oldest K920984 (1992). No later device cites it as a predicate yet.
- Root · 8 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 7 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 6 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 5 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 4 generations backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- 3 generations backK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- 2 generations backK171816 Kardia Band SystemAliveCor, Inc. · 2017
- 1 generation backK181823 KardiaAIAliveCor, Inc. · 2019
- This deviceK200884 B-Secur HeartKey Software LibraryB-Secur, Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −7 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −6 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −5 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −4 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| −3 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| −2 | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| −1 | K181823 | KardiaAI | AliveCor, Inc. | 2019 | — |
| 0 (this device) | K200884 | B-Secur HeartKey Software Library | B-Secur, Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K181823 | KardiaAISummary page 4…DPS Regulation: 21CFR 870.2340 Class: Class II Predicate Device: K181823 – AliveCor, Inc. - KardiAI Device Description: The B-Secur HeartKey Software Library is an “object library”. An object library i… | 2019 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 20 ancestors has a recall of any class.
- 2 other devices also cite its predicate K181823.
How does its category compare?
All DPS devicesDPS Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 B-Secur HeartKey Software Library is intended to be used by medical device manufacturers in medical devices to assess a single lead ECG spot checks from adult patients. The product allows the processing and extraction of beats from an ECG signal to provide a heart rate reading and ECG rhythm analysis. The library will classify a 30 second ECG spot check recording as normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia, unreadable or…
Read the full statement (132 words)
The B-Secur HeartKey Software Library is intended to be used by medical device manufacturers in medical devices to assess a single lead ECG spot checks from adult patients. The product allows the processing and extraction of beats from an ECG signal to provide a heart rate reading and ECG rhythm analysis. The library will classify a 30 second ECG spot check recording as normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia, unreadable or inconclusive.
The library is intended to be integrated into other device software. All interpretations must be reviewed by a medical professional for clinical decision making, and the user of the device should not make changes to their medication without consulting a physician.
The library is not intended for use in life supporting or sustaining systems, or cardiac alarm systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200884 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200884: B-Secur HeartKey Software Library.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200884
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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