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- (1) Digital Blood Pressure Monitor, Model Md-250

by Meditec Co., Ltd.

510(k) K990380

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 · Traditional NumberK990380 Date22 Feb 1999ClearedStatusActive

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  • Withdrawn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
Models / Variants
(1) Digital Blood Pressure Monitor, Model Md-250
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 Digital Blood Pressure Monitor, Models MD-250 and MD-700, are noninvasive blood pressure measurement systems. These devices use transducers placed on the surface of the body to derive and display systolic, diastolic, and mean arterial pressure readings automatically. The MD-250 serves as a basic digital monitor, while the MD-700 is a fully automatic model designed for enhanced convenience and accuracy in clinical or home settings.

These devices are intended for single-use or reusable applications, depending on manufacturer guidelines, and are classified under FDA product code DXN. Both models received FDA 510(k) clearance (K990380) as substantially equivalent to predicate devices, ensuring compliance with regulatory standards for noninvasive blood pressure measurement. They are supplied as standalone units and require no additional sterilization, as they are not classified as sterile medical devices.

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Questions

AI-generated answers, 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.

  • What are the Digital Blood Pressure Monitor Models MD-250 and MD-700 used for?

    These devices are noninvasive blood pressure measurement systems that automatically derive and display systolic, diastolic, and mean arterial pressure readings. The MD-250 is a basic digital monitor, while the MD-700 offers enhanced convenience and accuracy for clinical or home use.

  • Are the MD-250 and MD-700 blood pressure monitors single-use or reusable?

    These devices can be used for single-use or reusable applications depending on the manufacturer's guidelines. They are not classified as sterile medical devices and do not require additional sterilization.

  • What regulatory status do the MD-250 and MD-700 blood pressure monitors have?

    Both models received FDA 510(k) clearance (K990380) as substantially equivalent to predicate devices, ensuring compliance with regulatory standards for noninvasive blood pressure measurement.

  • How are the Digital Blood Pressure Monitor Models MD-250 and MD-700 supplied?

    These devices are supplied as standalone units and do not require additional components or sterilization, as they are not classified as sterile medical devices.