Cardiovascular · 510(k) · 2020
KardiaAI
AliveCor, Inc.. Cleared by FDA on 12 November 2020 under submission K201985, product code DQK (computer, diagnostic, programmable). What FDA's record says, in FDA's words.
Device record · K201985
- Device. KardiaAIDEVICE
- Company. AliveCor, Inc.COMPANY
- Decision. 12 November 2020, 510(k), substantially equivalent (traditional review); received 17 July 2020DECISION
- Panel. CardiovascularPANEL
- Product code. DQK, Computer, Diagnostic, ProgrammableCODE
- Regulation. 21 CFR 870.1425, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
[807.92(a)(5)] 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: x Filtering ECG noise, x Reporting heart rate measurement from ECGs, x Detecting noisy ECGs, x 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, x Detecting QRS complexes in an ECG, x For ECGs detected as sinus rhythm, classifying individual beats as a PVC or non-PVC beat, and x 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.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedECG
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
- Mentionsadult patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 4,558 reports filed against devices carrying product code DQK. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
30 September 2026 · Malfunction · QUANTIEN · Abbott Medical · report 2184149-2026-00257
During a fractional flow reserve procedure with QUANTIEN, it was noted that the PA signals were not appearing on the monitor leading to the procedure being cancelled. There were no adverse patient consequences.
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18928
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18932
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18933
29 September 2026 · Malfunction · Smart Pressure Controller · Edwards LifeSciences · report 2015691-2026-18934
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code DQK, in Cardiovascular, from AliveCor, Inc., or cleared in 2020. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.