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Xltek 024495

by Xltek

Xltek 024495 is a Class II device made by Xltek, cleared under FDA 510(k) K180421 on 14 Mar 2018 and listed in FDA GUDID since 20 Nov 2018 (UDI-DI 00382830048231), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K180421

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00382830048231 UDI-DI Date20 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK180421 Date14 Mar 2018IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180421 decided 14 Mar 2018 Active
  • FDA GUDID UDI-DI 00382830048231 listed 20 Nov 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180421
  2. Listed FDA GUDID 00382830048231

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Xltek
Generic name
Electroencephalograph
Model / reference
024495
Primary DI / UDI-DI
00382830048231
510(k) Number
FDA product code
OMA
GMDN term
Electroencephalograph
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electroencephalograph

Cleared under the same submission (K180421)

and 5 more cleared under K180421

Similar devices in this category

Other devices filed under Electroencephalograph.

Other devices from Xltek

See all devices from Xltek →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)