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Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300)

by Xandar Kardian Korea Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 21 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809988780001 UDI-DI Date19 Jan 2024ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 21 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Multiple vital physiological parameter monitoring system, home-use
Model / Reference
XK300
Primary DI / UDI-DI
08809988780001
510(k) Number
FDA Product Code
BZQ, DRT
GMDN Term
Multiple vital physiological parameter monitoring system, home-use
Device Class
Class II
Regulation Number
868.2375, 870.2300
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K202464)

Other devices from Xandar Kardian Korea Inc.

Properties

  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No