Device Desk

Private service · Not FDA

FDA device establishment · Kennesaw, 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-3012302888As of September 30, 2026

QUIPMENT INC.

Registration 3012302888FEI 3012302888Kennesaw, GA

Owner/operator: Quipment 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
62
Added, last 12 months
19

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 62

CodeDeviceClassRegulationPremarket
CCJMicro+pro SmokerlyzerAnalyzer, Gas, Carbon-Monoxide, Gaseous-PhaseAdded Aug 11, 2026Class 221 CFR 868.1430K082315
EWOGSI PelloAudiometerClass 221 CFR 874.1050—
DLJMicro+pro SmokerlyzerCalibrators, Drug SpecificAdded Aug 11, 2026Class 221 CFR 862.3200K082315
GKGMIKRO 220; MIKRO 220R; UNIVERSAL 320; UNIVERSAL 320RCentrifuge, HematocritClass 221 CFR 864.6400—
FLLEar Thermometer Welch AllynContinuous Measurement ThermometerAdded Nov 26, 2025Class 221 CFR 880.2910K152748
FLLHealth Monitoring smartwatch EmpaticaContinuous Measurement ThermometerClass 221 CFR 880.2910K221282
GZOHealth Monitoring smartwatch EmpaticaDevice, Galvanic Skin Response MeasurementClass 221 CFR 882.1540K221282
LELHealth Monitoring smartwatch EmpaticaDevice, Sleep AssessmentClass 221 CFR 882.5050K221282
LBBHoggan ScientificDynamometer, Ac-PoweredClass 221 CFR 888.1240K162412
DPSKardiaMobile 6LElectrocardiographAdded Jan 14, 2026Class 221 CFR 870.2340K210753
DPSQuipmentElectrocardiographClass 221 CFR 870.2340K101403
DPSWelch Allyn, Inc.ElectrocardiographClass 221 CFR 870.2340K120865

and 50 more on your full dossier

What changed

  • Aug 11, 2026Listing added: CCJ — Micro+pro Smokerlyzer (K082315)
  • Aug 11, 2026Listing added: DLJ — Micro+pro Smokerlyzer (K082315)
  • Nov 26, 2025Listing added: FLL — Ear Thermometer Welch Allyn (K152748)
  • Jan 14, 2026Listing added: DPS — KardiaMobile 6L (K210753)
  • Jan 14, 2026Listing added: QDA — KardiaMobile 6L (K210753)
  • Feb 11, 2026Listing added: QBJ — Dexcom G7 (K240902)
  • Aug 25, 2026Listing added: FPA — Cleo 90 Infusion set (K042172)
  • Jun 19, 2026Listing added: LHI — Vented Vial Adapter 20mm (K213513)
  • Mar 4, 2026Listing added: BZG — MICROLAB SPIROMETER (K031102)
  • Nov 26, 2025Listing added: BZG — Easy-on-pc (K090034)
  • Dec 3, 2025Listing added: FFX — Endoflip Catheter (K130906)
  • May 12, 2026Listing added: DXH — Study Watch (K182456)
  • Jan 14, 2026Listing added: DXH — KardiaMobile 6L (K210753)
  • Jun 3, 2026Listing added: MNR — WatchPat300 (K222331)
  • Aug 11, 2026Listing added: LAS — Micro+pro Smokerlyzer (K082315)
  • Jul 29, 2026Listing added: HRW — Dynamometer Echo Muscle Tester (K971407)
  • Feb 18, 2026Listing added: HLS — Exophthalmometer
  • Apr 8, 2026Listing added: FRI — Scale 874
  • Feb 11, 2026Listing added: KGX — Dexcom G7 (K240902)
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.

Is this right?

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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