SMART METER LLC
Registration 3015109923FEI 3015109923Tampa, FL
Owner/operator: Smart Meter LLC
- Complaint File Establishment per 21 CFR 820.198
- 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
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 13
- Added, last 12 months
- 2
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
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 processWait 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 processRenew 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 listingReview 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 13
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| FLL | iDigiTempContinuous Measurement ThermometerAdded Jan 25, 2026 | Class 2 | 21 CFR 880.2910 | K172795 |
| CGA | iGlucose Meter KitGlucose Oxidase, Glucose | Class 2 | 21 CFR 862.1345 | K161790 |
| QRL | Lancing DeviceMultiple Use Blood Lancet For Single Patient Use Only | Class 2 | 21 CFR 878.4850 | K221970 |
| DQA | Pulse OximeterOximeter | Class 2 | 21 CFR 870.2700 | K172141 |
| QRK | Single Use LancetsSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | 21 CFR 878.4850 | K221507 |
| DXN | iBlood Pressure ClassicSystem, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 21 CFR 870.1130 | K202891 |
| DXN | iBlood Pressure Classic - Multi Cuff DeviceSystem, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 21 CFR 870.1130 | K240102 |
| DXN | iBlood Pressure PlusSystem, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 21 CFR 870.1130 | K221913 |
| DXN | iBlood PressureSystem, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 21 CFR 870.1130 | K170866 |
| DXN | iBlood Pressure ProSystem, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 21 CFR 870.1130 | K141160 |
| NBW | iGlucose TouchSystem, Test, Blood Glucose, Over The CounterAdded Feb 6, 2026 | Class 2 | 21 CFR 862.1345 | K240637 |
| NBW | iGlucose Meter KitSystem, Test, Blood Glucose, Over The Counter | Class 2 | 21 CFR 862.1345 | K161790 |
and 1 more on your full dossier
What changed
- Jan 25, 2026Listing added: FLL — iDigiTemp (K172795)
- Feb 6, 2026Listing added: NBW — iGlucose Touch (K240637)