OXILINE LLC
Registration 3018940143FEI 3018940143Miami, FL
Owner/operator: OXILINE LLC
- 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.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
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- 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
- 25
- Added, last 12 months
- 11
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 25
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| QAQ | Therma XS ProAdjunctive Predictive Cardiovascular IndicatorAdded Jan 26, 2026 | Class 2 | 21 CFR 870.2210 | K221704 |
| PUH | Scale MD ProAnalyzer, Body Composition, ExemptAdded Jan 26, 2026 | Class 2 | 21 CFR 870.2770 | — |
| DQR | Therma XS ProCannula, CatheterAdded Jan 26, 2026 | Class 2 | 21 CFR 870.1300 | K221704 |
| DQK | Therma XS ProComputer, Diagnostic, ProgrammableAdded Jan 26, 2026 | Class 2 | 21 CFR 870.1425 | K221704 |
| GXY | Electrode, cutaneousElectrode, Cutaneous | Class 2 | 21 CFR 882.1320 | K181234 |
| CGA | Gluco XS ProGlucose Oxidase, Glucose | Class 2 | 21 CFR 862.1345 | K160179 |
| QRL | LancetsMultiple Use Blood Lancet For Single Patient Use OnlyAdded Jan 26, 2026 | Class 2 | 21 CFR 878.4850 | K220475 |
| DQA | Pulse Oximeter AOJ-70A, AOJ-70B, AOJ-70C, AOJ-70D, AOJ-70EOximeter | Class 2 | 21 CFR 870.2700 | K202173 |
| DQA | OximeterOximeter | Class 2 | 21 CFR 870.2700 | K232989 |
| DQA | Pulse MD PROOximeter | Class 2 | 21 CFR 870.2700 | K142687 |
| MUD | Therma XS ProOximeter, Tissue SaturationAdded Jan 26, 2026 | Class 2 | 21 CFR 870.2700 | K221704 |
| DSB | Therma XS ProPlethysmograph, ImpedanceAdded Jan 26, 2026 | Class 2 | 21 CFR 870.2770 | K221704 |
and 13 more on your full dossier
What changed
- Jan 26, 2026Listing added: QAQ — Therma XS Pro (K221704)
- Jan 26, 2026Listing added: PUH — Scale MD Pro
- Jan 26, 2026Listing added: DQR — Therma XS Pro (K221704)
- Jan 26, 2026Listing added: DQK — Therma XS Pro (K221704)
- Jan 26, 2026Listing added: QRL — Lancets (K220475)
- Jan 26, 2026Listing added: MUD — Therma XS Pro (K221704)
- Jan 26, 2026Listing added: DSB — Therma XS Pro (K221704)
- Jan 26, 2026Listing added: QUH — Hear 9S Pro (K221052)
- Jan 26, 2026Listing added: QRK — Lancets (K220475)
- Jan 26, 2026Listing added: DXN — Therma XS Pro (K221704)
- Jan 26, 2026Listing added: IQE — TENS Q Pro