Device Desk

Private service · Not FDA

FDA device establishment · Peachtree City, GA

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

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-3010082909As of September 30, 2026

Emsere, Inc.

Registration 3010082909FEI 3010082909Peachtree City, GA

Owner/operator: Emsere, Inc

  • 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
74
Added, last 12 months
12

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 74

CodeDeviceClassRegulationPremarket
QERClarus 700Camera, Ophthalmic, Slit-ScanningAdded Sep 8, 2026Class 221 CFR 886.1120K243878
DSIFaros 180 and Omega ElectrodesDetector And Alarm, ArrhythmiaClass 221 CFR 870.1025K182030
PSZQUIDEL CORP.Devices Detecting Influenza A, B, And C Virus AntigensClass 221 CFR 866.3328K112177
DPSMORTARA INSTRUMENT, INCElectrocardiographClass 221 CFR 870.2340K100127
DPSWelch AllynElectrocardiographClass 221 CFR 870.2340K122073
DPSMortara ELI150C ElectrocardiographElectrocardiographClass 221 CFR 870.2340K101115
DPSMortara ELI250/ELI250C ElectrocardiographElectrocardiographClass 221 CFR 870.2340K101403
MWJMortara H12+ digital holter recorderElectrocardiograph, Ambulatory (Without Analysis)Class 221 CFR 870.2800K021373
MLOGlobal Instrumentation M12R Holter recorderElectrocardiograph, Ambulatory, With Analysis AlgorithmClass 221 CFR 870.2800K051730
MLOFaros 180 and Omega ElectrodesElectrocardiograph, Ambulatory, With Analysis AlgorithmClass 221 CFR 870.2800K182030
CAHET Green - Expiratory filter & mouthpiece for MIP/MEP measurementFilter, Bacterial, Breathing-CircuitAdded Jun 18, 2026Class 221 CFR 868.5260K190022
BSNMILLEX - MP FILTER UNIT - (SLMPO25SS/SLMPL25SS)Filter, Conduction, AnestheticAdded Jun 17, 2026Class 221 CFR 868.5130K963717

and 62 more on your full dossier

What changed

  • Sep 8, 2026Listing added: QER — Clarus 700 (K243878)
  • Jun 18, 2026Listing added: CAH — ET Green - Expiratory filter & mouthpiece for MIP/MEP measurement (K190022)
  • Jun 17, 2026Listing added: BSN — MILLEX - MP FILTER UNIT - (SLMPO25SS/SLMPL25SS) (K963717)
  • Jun 9, 2026Listing added: IYN — Sonoscape E11 incl. Lineair Transducer 18L-A (K252498)
  • Jun 9, 2026Listing added: IYO — Sonoscape E11 incl. Lineair Transducer 18L-A (K252498)
  • Jun 15, 2026Listing added: MXA — Niox Vero (K101034)
  • Jun 8, 2026Listing added: MXA — Niox Vero Airway Inflammation Monitor - (K133898) (K133898)
  • Jun 8, 2026Listing added: MXA — Niox Vero - System, Test, Breath Nitric Oxide (K170983) (K170983)
  • Jun 8, 2026Listing added: MXA — Niox Vero Airway Inflammation Monitor - (K150233) (K150233)
  • Jun 9, 2026Listing added: ITX — Sonoscape E11 incl. Lineair Transducer 18L-A (K252498)
  • Sep 14, 2026Listing added: HRW — Jamar® Plus+ Hand Dynamometer
  • Apr 29, 2026Listing added: HPT — Humprey Field Analyzer 3 (HFA3) Model: 830, 840, 850, 860
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

We keep this page current each week. We email you before each date in the window, and when FDA’s record shows you renewed.

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Renews each year until you cancel. Cancel any time from your account.

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We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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