ClearanceBrief
Company ยท CN

SteriLance Medical (Suzhou), Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.

11510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature4
QRKSingle Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature4
QRLMultiple Use Blood Lancet For Single Patient Use Only2
FMINeedle, Hypodermic, Single Lumen1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Aug 25, 2026K262631Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
SteriLance Medical (Suzhou), Inc., CN
QRK
Jul 6, 2026K260122Lancing Device (PressGo, LDE3, LDE3AST, LDE5, EasyStep)
SteriLance Medical (Suzhou), Inc., CN
QRL
Jun 12, 2026K261634Disposable Blood Lancet (Soft)
SteriLance Medical (Suzhou), Inc., CN
QRK
Feb 26, 2025K244036Heel Incision Safety Lancet (SteriHeel 2)
SteriLance Medical (Suzhou), Inc., CN
FMK
Feb 26, 2025K244031Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposab
SteriLance Medical (Suzhou), Inc., CN
QRK
Jan 16, 2024K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable
SteriLance Medical (Suzhou), Inc., CN
FMK
Oct 28, 2022K221521Disposable Safety Lancet
SteriLance Medical (Suzhou), Inc., CN
FMK
Aug 31, 2022K221507Disposable Blood Lancet
SteriLance Medical (Suzhou), Inc., CN
QRK
Aug 30, 2022K221970Lancing device
SteriLance Medical (Suzhou), Inc., CN
QRL
Aug 26, 2021K210745Heel Incision Safety Lancet
SteriLance Medical (Suzhou), Inc., CN
FMK
Aug 29, 2016K153706Insulin Pen Needle
SteriLance Medical (Suzhou), Inc., CN
FMI

Latest recalls

DateFirm and productCodeLinked 510(k)
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