Data / Medical devices / United States / embecta medical I LLC
embecta medical I LLC: FDA-registered device maker in Holdrege, NE, United States, 4 510(k) clearances
embecta medical I LLC is registered with the FDA (registration 3024508819) in Holdrege, NE, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 13, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3024508819
- Address
- 1329 West Highway 6, Holdrege, NE, United States, 68949
- Owner or operator
- embecta Corp. (10084714)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- October 18, 2022
- Registered through
- 2027
- Brand names listed
- BD SafetyGlide, BD SafetyGlide Insulin Syringe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 13, 2026 | K260208 | Ultra-Fine SAFETY Insulin Syringe | FMF | Substantially Equivalent | embecta Medical II, LLC | accessdata.fda.gov |
| March 9, 2022 | K212499 | BD Insulin Syringe (0.3mL) | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| November 19, 2021 | K212015 | BD Nano 2nd Gen Pen Needle | FMI | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
| October 21, 2019 | K190054 | BD Insulin Syringe | FMF | Substantially Equivalent | Becton, Dickinson and Company | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
- All makers of Needle, Hypodermic, Single Lumen
Updated July 13, 2026. 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.