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I-Portal NOTC, VNG and VOG

by Neuro Kinetics, Inc.

510(k) K143607

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK143607 Date8 Jul 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2730-2015 FDA Class II initiated 21 Jul 2015

    The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.

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  • Withdrawn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
GWN
Device Class
Class II
Regulation
21 CFR Part 882.1460
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Neuro Kinetics, Inc.