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 Nov 12, 2020 as substantially equivalent to K181823 (AliveCor, Inc., 2019) after a 118-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Nov 12, 2020
- Review
- 118 days
- Class
- Class II
- Product code
- DQK
- 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 deviceK201985 KardiaAIAliveCor, Inc. · 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) | K201985 | KardiaAI | AliveCor, Inc. | 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 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 26.7 · 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 |
|---|---|---|---|
| * | K181823 | KardiaAISummary page 4…Class II Product Code DQK Subsequent Product Code DPS Predicate Information [807.92(a)(3)] Predicate(s) AliveCor, Inc., KardiaAI, K181823 Device Description [807.92(a)(4)] KardiaAI is a software library that implements various ECG processing and analysis algorithms.… | 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 4 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 DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). 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…
Read the full statement (199 words)
KardiaAI is a software analysis library intended to assess ambulatory electrocardiogram (ECG) rhythms from adult subjects (when prescribed or used under the care of a physician). 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 KardiaAI library provides the following capabilities:
• Filtering ECG noise,
• Reporting heart rate measurement from ECGs,
• Detecting noisy ECGs,
• Reporting ECG rhythm analysis for the presence of sinus rhythm, atrial fibrillation, bradycardia, and tachycardia; for ECGs detected as sinus rhythm, detecting normal sinus rhythm, sinus rhythm with wide QRS, sinus rhythm with premature ventricular contractions (PVC), and sinus rhythm with supraventricular ectopy,
• Detecting QRS complexes in an ECG,
• For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC beat, and
• Generating an average beat from an ECG
The device is not intended for use in patients who have pacemakers, ICDs, or other implanted electronic devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201985 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201985: KardiaAI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201985
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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