510(k) · Cleared
ClearedKardiaAI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
AliveCor, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Mar 11, 2019 as substantially equivalent to K171816 (AliveCor, Inc., 2017) and 1 other predicate after a 245-day review. Its family tree reaches back 7 generations to 1997. 6 later devices descend from it.
- Decided
- Mar 11, 2019
- Review
- 245 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K963725 (1997). 19 ancestors in all, the oldest K920984 (1992). 6 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 6 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 5 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 4 generations backK122184 Ecg CheckCardiac Designs, LLC · 2013
- 3 generations backK140933 Alivecor Heart MonitorAliveCor, Inc. · 2014 · Recalled
- 2 generations backK142743 AliveCor Heart MonitorAliveCor, Inc. · 2015
- 1 generation backK171816 Kardia Band SystemAliveCor, Inc. · 2017
- This deviceK181823 KardiaAIAliveCor, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK183319 Triangle SystemAliveCor, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK210753 KardiaMobile 6LAliveCor, Inc. · 2021
- Descendant · 3 generations on · 0 of its ownK231424 HeartBeam AIMIGo (TM) SystemHeartbeam, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK220350 KardiaMobile 6LAliveCor, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK200884 B-Secur HeartKey Software LibraryB-Secur, Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K183319Triangle SystemAliveCor, Inc. · 2019 · cites it directly3descendants
- K210753KardiaMobile 6LAliveCor, Inc. · 2021 · 2 generations on2descendants
- K231424HeartBeam AIMIGo (TM) SystemHeartbeam, Inc. · 2024 · 3 generations on0descendants
- K220350KardiaMobile 6LAliveCor, Inc. · 2022 · 3 generations on0descendants
- K200884B-Secur HeartKey Software LibraryB-Secur, Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −6 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −5 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −4 | K122184 | Ecg Check | Cardiac Designs, LLC | 2013 | — |
| −3 | K140933 | Alivecor Heart Monitor | AliveCor, Inc. | 2014 | 1 |
| −2 | K142743 | AliveCor Heart Monitor | AliveCor, Inc. | 2015 | — |
| −1 | K171816 | Kardia Band System | AliveCor, Inc. | 2017 | — |
| 0 (this device) | K181823 | KardiaAI | AliveCor, Inc. | 2019 | — |
| +1 | K183319 | Triangle System | AliveCor, Inc. | 2019 | — |
| +2 | K210753 | KardiaMobile 6L | AliveCor, Inc. | 2021 | — |
| +3 | K231424 | HeartBeam AIMIGo (TM) System | Heartbeam, Inc. | 2024 | — |
| +3 | K220350 | KardiaMobile 6L | AliveCor, Inc. | 2022 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K171816 | Kardia Band SystemSummary page 5…Page 1 of 6 510(k) SUMMARY PREDICATE DEVICE(S) [807.92(a)(3)] • Primary predicate: AliveCor, Inc., Kardia Band System, K171816 • Secondary predicate: CardioLogs Technologies, CardioLogs ECG Analysis Platform, K170568 DEVICE DESCRIPTION… | 2017 |
| * | K170568 | CardioLogs ECG Analysis PlatformSummary page 5…• Primary predicate: AliveCor, Inc., Kardia Band System, K171816 • Secondary predicate: CardioLogs Technologies, CardioLogs ECG Analysis Platform, K170568 DEVICE DESCRIPTION [807.92(a)(4)] KardiaAI is a software library that implements various ECG processing and analysis algor… | 2017 |
What descends from it? (6)
3 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 22 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K183319 (AliveCor, Inc., 2019) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K171816.
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?
The KardiaAl is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm…
Read the full statement (120 words)
The KardiaAl is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects. The device supports analyzing data recorded in compatible formats from any ambulatory ECG devices such as event recorders, or other similar devices. The library is intended to be integrated into other device software. The library is not intended for use in life supporting, or sustaining systems, or ECG monitors, or cardiac alarm, or OTC use only devices.
The KardiaAl library provides the following capabilities:
ECG noise filtering,
heart rate measurement from ECGs,
detection of noisy ECGs, and
ECG rhythm analysis for detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia (when prescribed or used under the care of a physician).
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/K181823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181823: KardiaAI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181823
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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