Device Desk

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FDA device establishment · Charlotte, NC

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

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Renewal dossierDD-3012311599As of September 30, 2026

LIGHTNING X PRODUCTS, INC

Registration 3012311599FEI 3012311599Charlotte, NC

Owner/operator: Lightning X Products, Inc

  • Manufacture Medical Device
  • 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
36
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 36

CodeDeviceClassRegulationPremarket
DXQLightning X BP Cuff Aneroid SphygmomanometerBlood Pressure CuffAdded Aug 31, 2026Class 221 CFR 870.1120K081951
SDVLightning X Economy Digital ThermometerClinical Electronic ThermometerAdded Aug 31, 2026Class 221 CFR 880.2910—
FLLLightning X Digital ThermometerContinuous Measurement ThermometerAdded Aug 31, 2026Class 221 CFR 880.2910K202009
DQALightning X Pulse OximeterOximeterAdded Aug 31, 2026Class 221 CFR 870.2700K120502
DXNLightning X Upper Arm Blood Pressure MonitorSystem, Measurement, Blood-Pressure, Non-InvasiveAdded Aug 31, 2026Class 221 CFR 870.1130K160019
BTMLightning X Adult Manual ResuscitatorVentilator, Emergency, Manual (Resuscitator)Added Aug 31, 2026Class 221 CFR 868.5915K210288
BTQNasopharyngeal (Nasal) Airway Kit 6 pcs NPAAirway, NasopharyngealAdded Nov 17, 2025Class 121 CFR 868.5100—
CAELightning X Berman Airway KitAirway, Oropharyngeal, AnesthesiologyAdded Aug 31, 2026Class 121 CFR 868.5110—
FQMLightning X Elastic Bandage 2"Bandage, ElasticAdded Aug 31, 2026Class 121 CFR 880.5075—
KMELightning X Emergency Foil BlanketBedding, Disposable, MedicalAdded Aug 31, 2026Class 121 CFR 880.6060—
CATEverready Nasal CannulaCannula, Nasal, OxygenAdded Aug 31, 2026Class 121 CFR 868.5340—
FZQLightning X Wound ZipsClip, Removable (Skin)Added Sep 1, 2026Class 121 CFR 878.4320—

and 24 more on your full dossier

What changed

  • Aug 31, 2026Listing added: DXQ — Lightning X BP Cuff Aneroid Sphygmomanometer (K081951)
  • Aug 31, 2026Listing added: SDV — Lightning X Economy Digital Thermometer
  • Aug 31, 2026Listing added: FLL — Lightning X Digital Thermometer (K202009)
  • Aug 31, 2026Listing added: DQA — Lightning X Pulse Oximeter (K120502)
  • Aug 31, 2026Listing added: DXN — Lightning X Upper Arm Blood Pressure Monitor (K160019)
  • Aug 31, 2026Listing added: BTM — Lightning X Adult Manual Resuscitator (K210288)
  • Nov 17, 2025Listing added: BTQ — Nasopharyngeal (Nasal) Airway Kit 6 pcs NPA
  • Aug 31, 2026Listing added: CAE — Lightning X Berman Airway Kit
  • Aug 31, 2026Listing added: FQM — Lightning X Elastic Bandage 2"
  • Aug 31, 2026Listing added: KME — Lightning X Emergency Foil Blanket
  • Aug 31, 2026Listing added: CAT — Everready Nasal Cannula
  • Sep 1, 2026Listing added: FZQ — Lightning X Wound Zips
  • Sep 11, 2026Listing added: ECX — Lightning X Aluminum D Oxygen Cylinder
  • Aug 31, 2026Listing added: MHW — Lightning X Compressed Krinkle Gauze
  • Sep 1, 2026Listing added: NAD — Lightning X Vented Chest Seal
  • Sep 1, 2026Listing added: OHO — Lightning X First Aid Kit
  • Aug 31, 2026Listing added: HTD — Lightning X Kelly Forceps
  • Aug 31, 2026Listing added: NAB — Lightning X 4"x4" Gauze Sponges
  • Sep 1, 2026Listing added: KGB — Everready Nonrebreather Mask
  • Aug 31, 2026Listing added: BYP — Lightning X CPR Mask
  • Sep 1, 2026Listing added: IQK — Lightning X Perfect Fit Adult Adjustable Extrication Cervical Collar
  • Aug 31, 2026Listing added: IMD — Lightning X Instant Cold Pack
  • Aug 31, 2026Listing added: HMP — Lightning X Oval Eye Pad
  • Aug 31, 2026Listing added: LZA — Lightning X Nitrile Gloves (K240361)
  • Aug 31, 2026Listing added: JOK — Lightning X Bandage Shears
  • Aug 31, 2026Listing added: ILI — Lightning X Triangle Bandage
  • Aug 31, 2026Listing added: ILH — Lightning X 12" Roll Splint
  • Aug 31, 2026Listing added: LDE — Lightning X Sprague Stethoscope
  • Aug 31, 2026Listing added: KGX — Lightning X 1" Cloth Medical Tape
  • Aug 31, 2026Listing added: GAX — Lightning X Buckle Tourniquet
  • Aug 30, 2026Listing added: LRR — Lightning X 269 Piece First Aid Kit OSHA ANSI Class A+, Soft Case Emergency Medical Kit - LXFAK-SF-A+
  • Aug 31, 2026Listing added: QSY — BattleSeal 3" x 48" Hemostatic Gauze (K211570)
  • Aug 31, 2026Listing added: LKB — Lightning X Alcohol Prep Pads
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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