510(k) Report

Devices descending from K221507

5 later devices reach Disposable Blood Lancet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261634Disposable Blood Lancet (Soft)SteriLance Medical (Suzhou), Inc.20260—
+1K250016droplet® personal lancetsHtl-Strefa S.A20250—
+1K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood…SteriLance Medical (Suzhou), Inc.20251—
+1K241810MICROLET®NEXT LancetAscensia Diabetes Care U.S., Inc.20240—
+2K262631Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)SteriLance Medical (Suzhou), Inc.20260—