Data / Medical devices / United States / Onetouch Medical, LLC
Onetouch Medical, LLC: FDA-registered device maker in Cypress, TX, United States, 1 510(k) clearance
Onetouch Medical, LLC is registered with the FDA (registration 3042953454) in Cypress, TX, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3042953454
- Address
- 19005 FM 529 RD Ste 11a-11b, Cypress, TX, United States, 77433
- Owner or operator
- ONETOUCH MEDICAL, LLC (10094657)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- December 14, 2025
- Registered through
- 2026
- Brand names listed
- EASYTOUSE INSULIN SYRINGE, EASYTOUSE U-100 INSULIN SYRINGE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler, Specification developer | 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 |
|---|---|---|---|---|---|---|
| September 12, 2019 | K190002 | Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use | FMF | Substantially Equivalent | Shanghai Kohope Medical Devices Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 12, 2019. 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.