FDA.reportPublic FDA data

HeartKey Rhythm

Primary DI
05061136120012
Brand
HeartKey Rhythm
Company
B-SECUR LIMITED
Model
HKR
Device description
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.
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DPSElectrocardiograph
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPSElectrocardiographCardiovascular2
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233755000HeartKey® RhythmB-Secur Limited2024-08-16DQK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05061136120012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05061136120012050611361200125061136120012

Regulatory Flags#

DUNS number
423636976
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05061136120005HeartKey Edge ECGHKE2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05061136120005HeartKey Edge ECGB-SECUR LIMITEDDQK2026-11-05
05061136120005HeartKey Edge ECGB-SECUR LIMITEDDPS2026-11-05
00191506063191OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-10-28
04719872982296QT ECGQt Medical, Inc.DPS2026-10-28
04719872982302QT ECGQt Medical, Inc.DPS2026-10-28
08800159500060S-Patch CardioAIWellysis Corp.DPS2026-10-27
08800159500060S-Patch CardioAIWellysis Corp.DQK2026-10-27
00860009793538STAR ArtemisRhythm AI Inc.DQK2026-10-26
00860011800613CardioTagCARDIOSENSE, INC.DPS2026-10-14
00195278840202MACGe Medical Systems Information Technologies, Inc.DQK2026-10-13
00195278840202MACGe Medical Systems Information Technologies, Inc.DPS2026-10-13
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDPS2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDPS2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDPS2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDPS2026-10-04
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05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-09-20
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