TD-5010 Lancing Device and TD-5084 Sterile Lancets (K221419)
Description
TD-5010 Lancing Device and TD-5084 Sterile Lancets by Gostar Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221419
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TD-5010 Lancing Device and TD-5084 Sterile Lancets (K221419) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K214022 | Accu-Chek Softclix Blood Lancing System | Roche Diabetes Care, Inc. | 2022 |
Trace the full predicate network for K221419
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.