Class Class II
droplet® personal lancets (K250016)
Description
droplet® personal lancets by Htl-Strefa S.A, an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250016
Clearance Date2025-07-01
Clearance TypeTraditional
Product CodeQRK
Regulation Number878.4850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250016
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. droplet® personal lancets (K250016) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221507 | Disposable Blood Lancet | SteriLance Medical (Suzhou), Inc. | 2022 |
Trace the full predicate network for K250016
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.