Data / Medical devices / United States / Oxiline LLC
Oxiline LLC: FDA-registered device maker in Miami, FL, United States, 14 510(k) clearances
Oxiline LLC is registered with the FDA (registration 3018940143) in Miami, FL, United States. It lists 18 device types. The FDA files 14 510(k) clearances under its listings, the newest dated July 1, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018940143
- Address
- 140 NW 37th ST, Miami, FL, United States, 33127
- Owner or operator
- OXILINE LLC (10081725)
- Roles
- Repackager or relabeler
- First device listed
- August 17, 2021
- Registered through
- 2026
- Brand names listed
- Andesfit ADF-B27 blood glucose monitoring system; Bioland blood glucose monitoring system; Bioland G-427B blood glucose, Electrode, cutaneous, Electronic Blood Pressure Monitor, Elite-X Pads, Gluco X Pro, Gluco XS Pro, Gluxo XS Pro, Hear 9S Pro and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 1, 2024 | K232989 | Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pulse Oximeter (AOJ-70D); Pulse Oximeter (AOJ-70E) | DQA | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 25, 2023 | K221052 | Self-Fitting hearing aids | QUH | Substantially Equivalent | Huizhou Jinghao Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 1, 2022 | K222125 | Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 22, 2022 | K221704 | HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) | DQK | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| April 1, 2022 | K220005 | TENS & PMS Unit | NUH | Substantially Equivalent | Shenzhen Yuehua Xinsen Technology Co., Ltd. | accessdata.fda.gov |
| February 18, 2022 | K213503 | Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| December 7, 2020 | K202173 | Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| March 20, 2020 | K191657 | Bioland Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bioland Technology, Ltd. | accessdata.fda.gov |
| March 3, 2019 | K182495 | Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
| December 19, 2018 | K173140 | VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System | NBW | Substantially Equivalent | Vivachek Laboratories, Inc. | accessdata.fda.gov |
| August 7, 2018 | K181234 | Self-adhesive Electrode | GXY | Substantially Equivalent | Dong Guan OU Kang Electronics Co., Ltd. | accessdata.fda.gov |
| April 21, 2017 | K160179 | VivaChek Ino Blood Glucose Monitoring System | NBW | Substantially Equivalent | Vivachek Laboratories, Inc. | accessdata.fda.gov |
| April 13, 2015 | K142687 | Pulse Oximeter | DQA | Substantially Equivalent | Shanghai Berry Electronic Tech Co., Ltd. | accessdata.fda.gov |
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Updated July 1, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.