FDA.reportPublic FDA data

HeartKey Edge ECG

Primary DI
05061136120005
Brand
HeartKey Edge ECG
Company
B-SECUR LIMITED
Model
HKE
Device description
The B-Secur HeartKey Software Library is intended to be used by medical device manufacturers in medical devices to assess a single lead ECG spot checks from adult patients. The product allows the processing and extraction of beats from an ECG signal to provide a heart rate reading and ECG rhythm analysis. The library will classify a 30 second ECG spot check recording as normal sinus rhythm, atrial fibrillation, bradycardia, and tachycardia, unreadable or inconclusive. The library is intended to be integrated into other device software. All interpretations must be reviewed by a medical professional for clinical decision making, and the user of the device should not make changes to their medication without consulting a physician. The library is not intended for use in life supporting or sustaining systems, or cardiac alarm systems.
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
K200884000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200884000B-Secur HeartKey Software LibraryB-Secur , Ltd.2020-12-07DPS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05061136120005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05061136120005050611361200055061136120005

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
05061136120012HeartKey RhythmHKR2026-11-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05061136120012HeartKey RhythmB-SECUR LIMITEDDQK2026-11-05
05061136120012HeartKey RhythmB-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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00810209880187CORE 500 Digital Stethoscope - Ember ChestpieceEko Health, Inc.DPS2026-10-01
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-09-20
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