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Medilog Optima

by Oxford Medilog, Inc. 510(k)

Active United States

510(k) K896535

Overview

The Medilog Optima is a blood-pressure monitoring computer system, designed for continuous ambulatory blood pressure measurement. It records and stores blood pressure readings over extended periods, enabling long-term cardiovascular assessment and analysis in clinical and research settings.

This device is supplied as a reusable medical instrument, intended for use in clinical environments such as hospitals, outpatient clinics, and research facilities. It operates under FDA 510(k) clearance (K896535) as a Class II device, adhering to regulatory standards for cardiovascular monitoring equipment. No specific sterility or MRI safety information is provided in the data.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK896535 Date18 Jan 1990ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSK
Device Class
Class II
Regulation
21 CFR Part 870.1110
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Medilog Optima primarily used for in clinical settings?

    The Medilog Optima is designed for continuous ambulatory blood pressure monitoring, allowing healthcare providers to record and analyze blood pressure readings over extended periods. This is particularly useful for long-term cardiovascular assessment in patients, enabling better evaluation of conditions like hypertension or other cardiovascular concerns in clinical, hospital, or research environments.

  • Is the Medilog Optima a single-use or reusable device, and how should it be maintained?

    The Medilog Optima is explicitly described as a reusable medical instrument, intended for use in clinical environments like hospitals and outpatient clinics. Since it is reusable, proper cleaning, disinfection, and maintenance protocols must be followed as per facility guidelines to ensure accuracy, reliability, and patient safety over repeated use.

  • How was the Medilog Optima approved by the FDA, and what regulatory pathway was followed?

    The Medilog Optima received FDA clearance through a 510(k) premarket notification process, specifically under the Traditional Review pathway. It was classified as a Class II device and determined to be *substantially equivalent* to a predicate device, adhering to FDA standards for cardiovascular monitoring systems. The clearance number is K896535, filed in 1989 and decided in 1990.

  • Are there any special considerations for storage or handling of the Medilog Optima?

    The provided data does not specify any special sterility requirements or MRI safety information for the Medilog Optima. However, as a reusable medical device, it should be stored in a clean, dry environment to prevent contamination or damage. Follow manufacturer guidelines for proper calibration, maintenance, and storage to ensure optimal performance and longevity.