Cleared Special

K261929 - Upper Arm Blood pressure monitor (BP7155D)

K261929 is an FDA 510(k) clearance for Upper Arm Blood pressure monitor (BP7155D), manufactured by Omron Healthcare, Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Special 510(k) pathway after a 93-day FDA review.

K261929 · Omron Healthcare, Inc. · Cardiovascular device
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Sep 2026
Decision
93d
Days
Class 2
Risk

K261929 is an FDA 510(k) clearance for the Upper Arm Blood pressure monitor (BP7155D). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Omron Healthcare, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on September 10, 2026 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Omron Healthcare, Inc. devices

FDA 510(k) Submission Details - K261929

510(k) Number K261929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2026
Decision Date September 10, 2026
Days to Decision 93 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Modification to existing cleared device.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

All 990
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