510(k) K212530 ยท LHI Set, I.V. Fluid Transfer
IVX Fluid Transfer Set
| Applicant | Omnicell, Inc., Cranberry PA, US |
| Decision | Substantially Equivalent, Apr 24, 2022 |
| Received | Aug 11, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212530
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2025 | Omnicell, Inc. IVX Station Reconstitution Transfer Set. Model Number: 298921215. Packaging: 1 set per White Tyvek Pouch, 5 Tyvek Pouches per shelf box, 10 shelf boxes per case box.
IVX Station Reconstitution Transf Open, Classified |
LHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.