Device Desk

Private service · Not FDA

FDA device establishment · Doral, FL

This page shows the yearly renewal for this site, from FDA’s public record.

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Renewal dossierDD-3010390468As of September 30, 2026

MEDISONO, LLC

Registration 3010390468FEI 3010390468Doral, FL

Owner/operator: Medisono, LLC

  • Repack or Relabel Medical Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
99
Added, last 12 months
33

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 99

CodeDeviceClassRegulationPremarket
CCKMB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand MedibluAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAdded Apr 9, 2026Class 221 CFR 868.1400K250179
CCLMB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand MedibluAnalyzer, Gas, Oxygen, Gaseous-PhaseAdded Apr 9, 2026Class 221 CFR 868.1720K250179
LMCSony UPD898MD UPX898MD Graphic PrintersCamera, Multi Format, RadiologicalAdded May 19, 2026Class 221 CFR 892.2040K141454
FDFVideo Endoscope SystemColonoscope And Accessories, Flexible/RigidClass 221 CFR 876.1500K211882
FDFVideo Endoscope SystemColonoscope And Accessories, Flexible/RigidClass 221 CFR 876.1500K173921
FDFVideo Endoscope SystemColonoscope And Accessories, Flexible/RigidClass 221 CFR 876.1500K222020
HEXVideo Colposcope DVC300 MEDISONO Brand MedibluColposcope (And Colpomicroscope)Added Apr 9, 2026Class 221 CFR 884.1630K160341
DSKMB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand MedibluComputer, Blood-PressureAdded Apr 9, 2026Class 221 CFR 870.1110K250179
DQKHA3P HOLTER SYSTEM MEDISONO Brand MedibluComputer, Diagnostic, ProgrammableAdded Apr 14, 2026Class 221 CFR 870.1425K151787
FLLMBV1 Vital Signs Monitor MEDISONO Brand MedibluContinuous Measurement ThermometerAdded Apr 9, 2026Class 221 CFR 880.2910K233038
FLLMB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand MedibluContinuous Measurement ThermometerAdded Apr 9, 2026Class 221 CFR 880.2910K250179
FLLMM3 VITAL SIGNS MONITOR MEDISONO Brand MedibluContinuous Measurement ThermometerAdded Apr 14, 2026Class 221 CFR 880.2910K120144

and 87 more on your full dossier

What changed

  • Apr 9, 2026Listing added: CCK — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 9, 2026Listing added: CCL — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • May 19, 2026Listing added: LMC — Sony UPD898MD UPX898MD Graphic Printers (K141454)
  • Apr 9, 2026Listing added: HEX — Video Colposcope DVC300 MEDISONO Brand Mediblu (K160341)
  • Apr 9, 2026Listing added: DSK — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 14, 2026Listing added: DQK — HA3P HOLTER SYSTEM MEDISONO Brand Mediblu (K151787)
  • Apr 9, 2026Listing added: FLL — MBV1 Vital Signs Monitor MEDISONO Brand Mediblu (K233038)
  • Apr 9, 2026Listing added: FLL — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 14, 2026Listing added: FLL — MM3 VITAL SIGNS MONITOR MEDISONO Brand Mediblu (K120144)
  • Apr 9, 2026Listing added: DSI — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 9, 2026Listing added: DPS — ECG MEDISONO Brand Mediblu ME3, ME6, ME12P, ME15P (K233266)
  • Apr 9, 2026Listing added: DPS — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 14, 2026Listing added: DPS — S12/S12W PCG ECG MEDISONO Brand Mediblu (K152427)
  • Apr 14, 2026Listing added: MWJ — HA3P HOLTER SYSTEM MEDISONO Brand Mediblu (K151787)
  • Apr 9, 2026Listing added: MLO — Blood Pressure Holter System HA5P MEDISONO Brand Mediblu (K101273)
  • Apr 14, 2026Listing added: DPW — FD1 Ultrasonic Pocket Doppler MEDISONO Brand Mediblu (K140579)
  • Apr 9, 2026Listing added: BZQ — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 9, 2026Listing added: DRT — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 14, 2026Listing added: MWI — BLU12+ Patient Monitor MEDISONO Brand Mediblu , BLU15+ Patient Monitor MEDISONO (K131898)
  • Apr 9, 2026Listing added: MWI — MBV1 Vital Signs Monitor MEDISONO Brand Mediblu (K233038)
  • Apr 9, 2026Listing added: MHX — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 9, 2026Listing added: MLD — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 14, 2026Listing added: KNG — FD1 Ultrasonic Pocket Doppler MEDISONO Brand Mediblu (K140579)
  • Apr 9, 2026Listing added: DQA — MBV1 Vital Signs Monitor MEDISONO Brand Mediblu (K233038)
  • Apr 14, 2026Listing added: DQA — MM3 VITAL SIGNS MONITOR MEDISONO Brand Mediblu (K120144)
  • Apr 9, 2026Listing added: DQA — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 14, 2026Listing added: DXN — HP50P Blood Pressure Holter System MEDISONO Brand Mediblu (K110156)
  • Apr 9, 2026Listing added: DXN — MB15 Patient Monitor MEDISONO Brand Mediblu, MB12 Patient Monitor MEDISONO Brand Mediblu (K250179)
  • Apr 9, 2026Listing added: DXN — MBV1 Vital Signs Monitor MEDISONO Brand Mediblu (K233038)
  • Apr 14, 2026Listing added: DXN — MM3 VITAL SIGNS MONITOR MEDISONO Brand Mediblu (K120144)
  • Apr 14, 2026Listing added: HGM — FM02 Fetal Monitor MEDISONO Brand Mediblu (K102140)
  • Apr 9, 2026Listing added: HGM — Central Patient Monitor System CMS4 MEDISONO Brand Mediblu (K143695)
  • Apr 14, 2026Listing added: HGL — FM02 Fetal Monitor MEDISONO Brand Mediblu (K102140)
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

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Keep this desk: $249 a year

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