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Mediblu MB12

by Mediblu Medical, LLC

Mediblu MB12 (MDB01046) is a Class II device made by Mediblu Medical, LLC, cleared under FDA 510(k) K250179 on 29 Jul 2025 and listed in FDA GUDID since 23 Dec 2025 (UDI-DI 00199874152509), 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) K250179

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 Number00199874152509 UDI-DI Date23 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250179 Date29 Jul 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250179 decided 29 Jul 2025 Active
  • FDA GUDID UDI-DI 00199874152509 listed 23 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250179
  2. Listed FDA GUDID 00199874152509

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mediblu
Generic name
Multiple vital physiological parameter monitoring system, clinical
Model / Ref / Catalog
MB12, MDB01046
Primary DI / UDI-DI
00199874152509
510(k) Number
FDA product code
MHX
GMDN term
Multiple vital physiological parameter monitoring system, clinical
Device class
Class II
Regulation number
870.1025
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K250179)

and 8 more cleared under K250179

Similar devices

Other devices filed under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)).

Other devices from Mediblu Medical, LLC

  • Mediblu MB15

    Class II

  • Mediblu MBV1 Open recall

    Class II

  • Mediblu FD1

    Class II

  • Mediblu MM17

    Class II

See all devices from Mediblu Medical, LLC →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)