Silver, Upper Arm Blood Pressure Monitor

Primary DI
00073796252601
Brand
Silver, Upper Arm Blood Pressure Monitor
Company
Omron Healthcare, Inc.
Model
BP5260
Device description
The Omron Upper Arm Blood Pressure Monitor is an OTC, at home use, upper arm blood pressure monitor. The device consists of a monitor and an arm cuff designed to be used on the upper arm. It is battery powered and can optionally be connected to an AC adapter. The proposed device measures blood pressure (systolic [SYS] and diastolic [DIA]) and pulse rate (PR), detects the presence of irregular heartbeats, and can also detect the possible presence of AFib by analyzing pulse pressure wave data captured during the user's blood pressure measurement to identify episodes of AFib and provides a notification on the display screen to the user. Additionally, the Monitor may be used with the Omron Connect mobile application ("App"), an optional software-only accessory residing on a consumer smart device which connects to the device via Bluetooth Low Energy (BLE) and transfers information on completed device recordings for storage and redisplay. When the measurement is complete, if atrial fibrillation has not been detected in the reading, and the time/date appear alternately. If atrial fibrillation is detected in the reading, the device displays the "Possible AFib" icon and furthermore, displays the characters "AF" in place of blood pressure readings. No blood pressure or pulse rate readings are displayed to the user
Published
2026-05-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
QXYOscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXYOscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification FeatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230076000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230076000Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ))Omron Healthcare, Inc.2024-10-08QXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00073796252601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00073796252601000737962526010737962526010073796252601

GMDN Terms#

Term, Definition table
TermDefinition
Automatic-inflation electronic sphygmomanometer, portable, arm/wristAn electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure00
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
8006344350ohiquality@omron.com

Regulatory Flags#

DUNS number
054318779
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
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
00073796451004Omron MicroAir Vibrating Mesh NebulizerNE-U100NE-U1002018-10-22
00073796800147Omron CompAir Compressor NebulizerRE-C800KDRE-C800KD2020-08-03
00073796451226Omron Micro Air Vibrating Mesh NebulizerNE-U22VNE-U22V2017-05-17
00073796453305Omron CompAir Elite Compact Compressor NebulizerNE-C30NE-C302017-05-17
00073796458010Omron CompAir Compressor NebulizerNE-C801NE-C8012017-05-17
00073796458034Omron CompAir Mini-NebulizerNE-C803NE-C8032017-05-17
00073796760069Upper Arm Blood Pressure MonitorHEM-7600T-CD6HEM-7600T-CD62025-07-15
10073796760066Upper Arm Blood Pressure MonitorHEM-7600T-CD6HEM-7600T-CD62025-07-15
00073796736538Blood Pressure MonitorBP7365CAN-CD6BP7365CAN-CD62025-06-27
10073796736535Blood Pressure MonitorBP7365CAN-CD6BP7365CAN-CD62025-06-27
00073796343927Omron Small D-ring CuffHEM-CS24-BHEM-CS24-B2019-04-03
00073796725310Omron 5 Series Upper Arm Blood Pressure MonitorBP7250CANBP7250CAN2019-07-08
00073796735319Omron 7 Series Upper Arm Blood Pressure MonitorBP7350CANBP7350CAN2019-07-08
00073796745318Omron 10 Series Upper Arm Blood Pressure MonitorBP7450CANBP7450CAN2019-07-08
00073796893101Blood Pressure Monitor BP9310TBP9310T2022-07-01
00073796745530Omron Blood Pressure MonitorBP7455CAN-CD6BP7455CAN-CD62021-09-01
00073796100315Omron 3 Series Upper Arm Blood Pressure MonitorBP7100CANBP7100CAN2019-07-08
00073796146054AC Adapter for digital Blood Pressure UnitsHEM-ADPTW5HEM-ADPTW52016-09-16
00073796149079AC Adapter for HEM-907XLHEM-ADPT907HEM-ADPT9072016-09-16
00073796330132AC Adapter for NE-C30C30AC2016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073796736538Blood Pressure MonitorOmron Healthcare, Inc.QXY2025-06-27
10073796736535Blood Pressure MonitorOmron Healthcare, Inc.QXY2025-06-27
00073796253608Gold Upper Arm Blood Pressure Monitor Omron Healthcare, Inc.QXY2025-01-25
10073796253605Gold Upper Arm Blood Pressure Monitor Omron Healthcare, Inc.QXY2025-01-25
00073796254650Platinum Upper Arm Blood Pressure Monitor Omron Healthcare, Inc.QXY2025-01-25
000737962736067 Series Upper Arm Blood Pressure MonitorOmron Healthcare, Inc.QXY2024-12-31
0007379627465810 Series Upper Arm Blood Pressure MonitorOmron Healthcare, Inc.QXY2024-12-31