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1500 Pro

by Omron Healthcare, Inc.

510(k) K080289

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK080289 Date26 Feb 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DXN
Device class
Class II
Regulation
21 CFR Part 870.1130
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 1500 Pro is a non-invasive blood pressure measurement system (product code DXN), designed for accurate and reliable monitoring of systolic and diastolic blood pressure. It falls under the FDA’s classification as a Class II device under Special Controls, intended for clinical and home use. The device employs an arm-in cuff style for measurement, ensuring compatibility with standard upper-arm blood pressure assessment protocols.

This device is supplied as a reusable system and is intended for use in clinical settings, physician offices, and home environments. It has received FDA 510(k) clearance under Special Controls for cardiovascular applications, with no restrictions on MRI safety as it is not magnetic resonance–compatible. Storage and maintenance instructions are manufacturer-specific, though the device’s arm-in cuff design requires proper sizing for accurate readings. The clearance (K080289) was granted in February 2008, affirming its substantial equivalence to predicate devices like the Omron HEM 780N3.

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