Class Class II
MICROLET®NEXT 2 Lancing Device (K250813)
Description
MICROLET®NEXT 2 Lancing Device by Ascensia Diabetes Care U.S., Inc., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250813
Clearance Date2025-05-14
Clearance TypeTraditional
Product CodeQRL
Regulation Number878.4850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250813
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. MICROLET®NEXT 2 Lancing Device (K250813) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221970 | Lancing device | SteriLance Medical (Suzhou), Inc. | 2022 |
Trace the full predicate network for K250813
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.