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Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E)

by Xandar Kardian Korea Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809988780049 UDI-DI Date4 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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-E
Primary DI / UDI-DI
08809988780049
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
In Commercial Distribution

Other devices from Xandar Kardian Korea Inc.

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

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