Device Desk

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FDA device establishment · Long Beach, NY

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

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Renewal dossierDD-3010419931As of September 30, 2026

SIGNA MEDICAL, INC.

Registration 3010419931FEI 3010419931Long Beach, NY

Owner/operator: Signa Medical, Inc.

  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device
  • Reprocess Single-Use 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
114
Added, last 12 months
28

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 114

CodeDeviceClassRegulationPremarket
KLETOOTH BONDING AGENTAgent, Tooth Bonding, ResinClass 221 CFR 872.3200K060684
KLEBondLink; Gloss 'N' Seal; LumiBrite Desensitizing Enhancer; Tenure Quik with Fluoride; Tenure S; Tenure Uni-BondAgent, Tooth Bonding, ResinClass 221 CFR 872.3200K801216
CCKMasimo RD SET, OXIMETERAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAdded Jan 6, 2026Class 221 CFR 868.1400K191059
FERANOSCOPEAnoscope And AccessoriesClass 221 CFR 876.1500K810227
DWMSUCTION APPARATUSApparatus, Suction, Patient CareClass 221 CFR 870.5050K160450
HRXSYSTEM, IRRIGATION, UROLOGICALArthroscopeClass 221 CFR 888.1100K960787
EWOAUDIOSCOPE,POCKET FIBER OTOSCOPE; 777 Wall Transformer Set (including Otoscopes, Ophthalmoscope) and accessoriesAudiometerAdded Mar 2, 2026Class 221 CFR 874.1050—
FCGBIOPSY NEEDLEBiopsy NeedleClass 221 CFR 876.1075K963565
DXQBP CUFFS (FLEXIPORT)Blood Pressure CuffAdded Feb 3, 2026Class 221 CFR 870.1120K251745
DXQBP Cuff- Durashock Sphygmomanometers, AccessoriesBlood Pressure CuffAdded Mar 2, 2026Class 221 CFR 870.1120K012455
FOZBECTON DICKINSONCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysClass 221 CFR 880.5200K013800
DQYCatheter, Percutaneous, IntroducerCatheter, PercutaneousAdded Dec 12, 2025Class 221 CFR 870.1250K122917

and 102 more on your full dossier

What changed

  • Jan 6, 2026Listing added: CCK — Masimo RD SET, OXIMETER (K191059)
  • Mar 2, 2026Listing added: EWO — AUDIOSCOPE,POCKET FIBER OTOSCOPE; 777 Wall Transformer Set (including Otoscopes, Ophthalmoscope) and accessories
  • Feb 3, 2026Listing added: DXQ — BP CUFFS (FLEXIPORT) (K251745)
  • Mar 2, 2026Listing added: DXQ — BP Cuff- Durashock Sphygmomanometers, Accessories (K012455)
  • Dec 12, 2025Listing added: DQY — Catheter, Percutaneous, Introducer (K122917)
  • Jan 6, 2026Listing added: FLL — Masimo RD SET, OXIMETER (K191059)
  • Dec 12, 2025Listing added: FAJ — FLEXOR VISION URETEROSCOPE AND ACCESSORIES (K072521)
  • Jan 6, 2026Listing added: DPS — MASIMO OXIMETER (K240229)
  • Dec 12, 2025Listing added: FED — FLEXOR VISION URETEROSCOPE AND ACCESSORIES (K072521)
  • Dec 12, 2025Listing added: FFS — FLEXOR VISION URETEROSCOPE AND ACCESSORIES (K072521)
  • Nov 10, 2025Listing added: KNA — POSTPARTUM BALLOON (K062438)
  • Dec 12, 2025Listing added: OQY — Intrauterine tamponade balloon (K170622)
  • Dec 12, 2025Listing added: FGA — FLEXOR VISION URETEROSCOPE AND ACCESSORIES (K072521)
  • Dec 12, 2025Listing added: GCJ — FLEXOR VISION URETEROSCOPE AND ACCESSORIES (K072521)
  • Jan 6, 2026Listing added: BZQ — Masimo RD SET, OXIMETER (K191059)
  • Jan 6, 2026Listing added: MWI — Masimo RD SET, OXIMETER (K191059)
  • Jan 6, 2026Listing added: DQA — MASIMO OXIMETER (K240229)
  • Jan 6, 2026Listing added: DQA — Masimo RD SET, OXIMETER (K191059)
  • Dec 22, 2025Listing added: DQA — Masimo RD SET, OXIMETER (K101896)
  • Apr 23, 2026Listing added: FMF — SYRINGE PISTON, NEEDLE, HYPODERMIC (K203453)
  • Jan 6, 2026Listing added: DXN — Masimo RD SET, OXIMETER (K191059)
  • Jan 6, 2026Listing added: DXH — MASIMO OXIMETER (K240229)
  • Dec 12, 2025Listing added: FGB — FLEXOR VISION URETEROSCOPE AND ACCESSORIES (K072521)
  • Feb 3, 2026Listing added: KZF — HALOGEN EXAMINATION LIGHT (K921493)
  • Feb 3, 2026Listing added: ERA — Welch Allyn LED Otoscope; Welch Allyn LumiView Clear Single-Use Ear Specula; (K952578)
  • Jan 6, 2026Listing added: JKS — Masimo RD SET, OXIMETER (K191059)
  • Mar 2, 2026Listing added: HMF — OPTHO/OTOSCOPE NON-POWERED
  • Feb 3, 2026Listing added: BZS — Stethoscope, Acoustic
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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