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Mediblu MBV1

by Mediblu Medical, LLC

Mediblu MBV1 (MDB01048) is a Class II device made by Mediblu Medical, LLC, cleared under FDA 510(k) K233038 on 8 Mar 2024 and listed in FDA GUDID since 23 Dec 2025 (UDI-DI 00199874784175), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K233038

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 Number00199874784175 UDI-DI Date23 Dec 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK233038 Date8 Mar 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K233038 decided 8 Mar 2024 Active
  • FDA GUDID UDI-DI 00199874784175 listed 23 Dec 2025 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1144-2026 FDA Class II initiated 24 Oct 2025

    As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

Timeline

3 dated events

  1. Cleared FDA 510(k) K233038
  2. Recall initiated FDA recalls Z-1144-2026
  3. Listed FDA GUDID 00199874784175

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  • Withdrawn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
MBV1, MDB01048
Primary DI / UDI-DI
00199874784175
510(k) Number
FDA product code
MWI
GMDN term
Multiple vital physiological parameter monitoring system, clinical
Device class
Class II
Regulation number
870.2300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K233038)

Similar devices

Other devices filed under FDA product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)).

Other devices from Mediblu Medical, LLC

  • Mediblu MB12

    Class II

  • Mediblu MB15

    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)