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MEL-16-1, MEL-16-3 & MEL-16-5 TDK ECG Electrodes

by Tdk Corp.

510(k) K863369

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 NumberK863369 Date6 Jan 1987ClearedStatusActive

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  • Withdrawn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
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The device is an ECG electrode used for cardiovascular monitoring. It is a substantially equivalent medical device cleared under the FDA 510(k) process with product code DRX.

It is supplied by Tdk Corp. and was cleared on January 6, 1987, under K863369. The device is intended for use in cardiovascular applications as indicated by the advisory committee classification.

Other devices from Tdk Corp.

Questions

AI-generated answers, 6 Oct 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 intended use of the MEL-16-1, MEL-16-3, and MEL-16-5 TDK ECG electrodes?

    These ECG electrodes are intended for cardiovascular monitoring applications, as indicated by their classification under the cardiovascular advisory committee and their clearance for use in cardiovascular applications.

  • How are the MEL-16-1, MEL-16-3, and MEL-16-5 TDK ECG electrodes supplied and by whom?

    The electrodes are supplied by Tdk Corp., as stated in the device data, with no additional details provided about packaging, sterility, or single-use versus reuse status in the available information.

  • What regulatory pathway was used for the clearance of the MEL-16-1, MEL-16-3, and MEL-16-5 TDK ECG electrodes?

    The device was cleared through the FDA 510(k) process as a substantially equivalent medical device, with clearance granted under K863369 on January 6, 1987, and assigned product code DRX.