SteriLance Medical (Suzhou), Inc.

FDA Regulatory Profile

SteriLance Medical (Suzhou), Inc. appears in FDA public data with 0 recalls, 11 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on August 25, 2026.

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K262631Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)August 25, 2026
K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)July 6, 2026
K261634Disposable Blood Lancet (Soft)June 12, 2026
K244036Heel Incision Safety Lancet (SteriHeel 2)February 26, 2025
K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (SofFebruary 26, 2025
K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancetJanuary 16, 2024
K221521Disposable Safety LancetOctober 28, 2022
K221507Disposable Blood LancetAugust 31, 2022
K221970Lancing deviceAugust 30, 2022
K210745Heel Incision Safety LancetAugust 26, 2021
K153706Insulin Pen NeedleAugust 29, 2016