HeartKey® Rhythm

K233755

B-Secur Limited · cleared 2024-08-16 · product code DQK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“HeartKey Rhythm is intended to automatically analyse ECG data and provide ECG signal processing and assessment of cardiac arrhythmias. The software processes the following types of ambulatory ECGs:”
Algorithmcombination of rules-based calculations and AI / ML technology
source quote (p.6)
“HeartKey Rhythm analyses the input ECG using a combination of rules-based calculations and AI / ML technology.”
Adaptive (vs locked)No
source quote (p.6)
“The software is compiled and remains static, with no further modification of the code carried out once deployed.”
PCCPNo
source quote (p.6)
“The software is compiled and remains static, with no further modification of the code carried out once deployed.”
Cybersecurity addressedYes
source quote (p.12)
“Cybersecurity testing was conducted in which no vulnerabilities were identified and all software requirements were satisfied.”

Validation studies (1)

Standalone

n=1,200 images

endpoints: sensitivity; specificity; positive predictive values

standards: ANSI/AAMI EC57:2012, ANSI/AAMI/IEC 60601-2-47:2012, IEC 62304:2006+A1:2015, IEC 81001-5-1:2022, General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January, 2002), Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Final Guidance for Industry and FDA Staff (September, 2023)

Reported performance (1 observation)

ppvas written: “positive predictive values”stated without value
source quote (p.12)
“Performance testing included the evaluation of metrics such as sensitivity, specificity, and positive predictive values.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

28
recalls in product code, 24mo
423
MAUDE reports in code, 12mo
-1%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom, initiated 2025-09-16): "Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97686

  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Boston Scientific Corporation, initiated 2024-09-05): "Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95331

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K233755