510(k) K212015 ยท FMI Needle, Hypodermic, Single Lumen
BD Nano 2nd Gen Pen Needle
| Applicant | Becton, Dickinson and Company, Franklin Lakes NJ, US |
| Decision | Substantially Equivalent, Nov 19, 2021 |
| Received | Jun 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212015
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | embecta Medical II LLC EWO_02512 (Catalog number 320550)
For Investigational Use Only
Nano Pro Un-Cannulated Demo Samples
Quantity 100 Open, Classified |
FMI | None listed |
| Jul 23, 2024 | Embecta Corp. BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral admin Open, Classified |
FMI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.