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Sensi-Prema Neonatal ECG Electrodes, 40612, 40614, 40626, 40550, 40554, 40555, 440556, 40610, 40613, 40625, 40801

by Niko Medical Products

510(k) K003804

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 · Abbreviated NumberK003804 Date30 Aug 2001ClearedStatusActive

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  • Withdrawn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, 27 Sep 2026

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

This device is a neonatal ECG electrode intended for use in cardiovascular applications. It is designed to detect and transmit electrical activity of the heart in neonatal patients.

The device is supplied as a set of electrodes with the specified model numbers and has received FDA 510(k) clearance under K003804. It is classified as a Class II medical device with an abbreviated clearance type and was found substantially equivalent to a predicate device.

Questions

AI-generated answers, 27 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 SENSI-PREMA Neonatal ECG Electrode used for?

    It is intended to detect and transmit electrical activity of the heart in neonatal patients during cardiovascular monitoring, as specified in the device description.

  • How is the SENSI-PREMA Neonatal ECG Electrode supplied and what models are included?

    The device is supplied as a set of electrodes including the model numbers 40612, 40614, 40626, 40550, 40554, 40555, 440556, 40610, 40613, 40625, and 40801.

  • Is the SENSI-PREMA Neonatal ECG Electrode sterile and intended for single use?

    The device data does not specify sterility or single-use/reuse status, so no conclusion can be drawn about these attributes from the provided information.

  • What regulatory pathway was used for the SENSI-PREMA Neonatal ECG Electrode?

    The device received FDA 510(k) clearance under K003804 and is classified as a Class II medical device with an abbreviated clearance type.