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FDA 510(k)

Upper Arm Blood pressure monitor (BP7155D)

K-Number: K261929 · 2026-09-10

ApplicantOMRON Healthcare, Inc.
Decision Date2026-09-10
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Upper Arm Blood pressure monitor (BP7155D) is the device name listed in this FDA 510(k) record. The listed applicant is OMRON Healthcare, Inc.. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K261929. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Upper Arm Blood pressure monitor (BP7155D)?

Upper Arm Blood pressure monitor (BP7155D) is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is OMRON Healthcare, Inc.. The 510(k) number is K261929.

When did Upper Arm Blood pressure monitor (BP7155D) receive FDA 510(k) clearance?

Upper Arm Blood pressure monitor (BP7155D) received FDA 510(k) clearance on 2026-09-10, under 510(k) number K261929.

Who is the listed applicant for Upper Arm Blood pressure monitor (BP7155D)?

The FDA 510(k) record lists OMRON Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Upper Arm Blood pressure monitor (BP7155D)?

The FDA product code for Upper Arm Blood pressure monitor (BP7155D) is DXN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing OMRON Healthcare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K202228Omron Model BP7900 Blood Pressure Monitor + EKGK183215Focus TENS Therapy, Model PM710-M/-LK190693HEM-6410T-ZL Wrist Blood Pressure MonitorK182579Omron Model BP7900 Blood Pressure Monitor + EKGK182120Maxpower ReliefK182481HEM-6410T-ZM Wrist Blood Pressure Monitor

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Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K261061BP Go (BPP-855)Wellvii, Inc.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261136Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D)Guangzhou Daxin Health Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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