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Blood Pressure Device, 400 Series

by Med-Tek Corp.

510(k) K781906

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 NumberK781906 Date16 Nov 1978ClearedStatusActive

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  • Withdrawn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, 28 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 Blood Pressure Device, 400 Series is a cardiovascular device used for measuring blood pressure. It is substantially equivalent to a predicate device as determined by FDA 510(k) clearance.

This device was cleared via the traditional 510(k) pathway under product code DXN and review by the Cardiovascular advisory committee. It is manufactured by Med-Tek Corp. and received FDA clearance on November 16, 1978, under K781906.

Other devices from Med-Tek Corp.

See all devices from Med-Tek Corp. →

Questions

AI-generated answers, 28 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 is the Blood Pressure Device, 400 Series used for?

    The Blood Pressure Device, 400 Series is a cardiovascular device used for measuring blood pressure, as stated in its description, and is intended for this clinical purpose based on its substantial equivalence to a predicate device.

  • How was the Blood Pressure Device, 400 Series cleared for market?

    The device was cleared via the traditional 510(k) pathway under product code DXN, with review by the Cardiovascular advisory committee, and received FDA clearance on November 16, 1978, under K781906 as substantially equivalent to a predicate device.

  • Who manufactures the Blood Pressure Device, 400 Series and where is it made?

    The Blood Pressure Device, 400 Series is manufactured by Med-Tek Corp., located at 803 N. Front St. Suite 3, Mchenry, IL 60050, United States, as indicated in the manufacturer and address fields.