Cardiovascular · 510(k) · 2024
HeartKey Rhythm
B-Secur Limited. Cleared by FDA on 16 August 2024 under submission K233755, product code DQK (computer, diagnostic, programmable). What FDA's record says, in FDA's words.
Device record · K233755
- Device. HeartKey RhythmDEVICE
- Company. B-Secur Limited (GB)COMPANY
- Decision. 16 August 2024, 510(k), substantially equivalent (traditional review); received 22 November 2023DECISION
- Panel. CardiovascularPANEL
- Product code. DQK, Computer, Diagnostic, ProgrammableCODE
- Regulation. 21 CFR 870.1425, Class IIREG
- Source. FDA database entry · decision document (13 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.
HeartKey Rhythm is intended for use by qualified healthcare professionals for analysing ECG data from adults. HeartKey Rhythm analyses a single ECG lead recorded from compatible devices used for arrhythmia diagnostics such as Holters, Extended Holters, ECG Patches, Event Recorders, or other similar devices when assessment of the rhythm is necessary. The HeartKey Rhythm application program interface (API) is intended to be integrated into other device software to provide the following capabilities: • ECG signal conditioning, • ECG signal quality assessment, • QRS beat detection, • Ventricular ectopic beat detection, • ECG rhythm analysis HeartKey Rhythm is not intended for use in life supporting, or sustaining systems, or real-time ECG monitors, or cardiac alarm devices, or OTC-use only devices. HeartKey Rhythm analysis results are not intended to be the sole means of diagnosis. It is offered to physicians and clinicians on an advisory basis only in conjunction with the physician’s knowledge of ECG patterns, patient background, clinical history, symptoms, and other diagnostic information.
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
- Mentionsa diagnostic claim
- 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, or cleared in 2024. 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.