Data / Medical devices / United States / Byflo LLC
Byflo LLC: FDA-registered device maker in Mountain House, CA, United States, 6 510(k) clearances
Byflo LLC is registered with the FDA (registration 3042579404) in Mountain House, CA, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated April 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042579404
- Address
- 491 N Napa Ln, Mountain House, CA, United States, 95391
- Owner or operator
- ByFlo LLC (10094320)
- Roles
- Repackager or relabeler
- First device listed
- November 23, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Repackager or relabeler | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| April 30, 2025 | K244000 | Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm Blood Pressure Monitor (ARM-30Q);Arm Blood Pressure Monitor (ARM-30E+); | DXN | Substantially Equivalent | Shenzhen AOJ Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 4, 2024 | K242721 | Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) | DXN | Substantially Equivalent | Shenzhen Finicare 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 |
| March 12, 2021 | K203707 | Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 | FLL | Substantially Equivalent | Shenzhen Zhengkang Technology Co., Ltd. | accessdata.fda.gov |
| April 3, 2019 | K182597 | Infrared thermometer | FLL | Substantially Equivalent | Shenzhen Pango Electronic Co., Ltd. | accessdata.fda.gov |
| March 14, 2018 | K172795 | Infrared Thermometer | FLL | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Continuous Measurement Thermometer
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
Updated April 30, 2025. 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.