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The Tracker / September 2026 / K261929

510(k) cleared

Upper Arm Blood pressure monitor (BP7155D)

OMRON Healthcare, Inc. · Sep 10, 2026 · K261929

FDA cleared the Upper Arm Blood pressure monitor (BP7155D) from OMRON Healthcare, Inc. on Sep 10, 2026 under K261929, a special 510(k). The device falls under product code DXN, System, Measurement, Blood-Pressure, Non-Invasive, regulated at 21 CFR 870.1130 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jun 9, 2026. The decision came 93 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for OMRON Healthcare, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261929?

K261929 is the FDA 510(k) for Upper Arm Blood pressure monitor (BP7155D), submitted by OMRON Healthcare, Inc.. FDA's decision date was Sep 10, 2026, under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Who makes the Upper Arm Blood pressure monitor (BP7155D)?

OMRON Healthcare, Inc., based in Hoffman Estates, IL, is the applicant of record for K261929.

How long did the K261929 review take?

FDA received the submission on Jun 9, 2026 and issued its decision on Sep 10, 2026, 93 days later.

← All decisions in September 2026