510(k) K221507

Disposable Blood Lancet by SteriLance Medical (Suzhou), Inc. — Product Code QRK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 31, 2022
Date Received: May 23, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Device Class: Class II
Regulation Number: 878.4850
Review Panel: SU
Submission Type

A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Other clearances by SteriLance Medical (Suzhou), Inc.

K244031 — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposab (February 26, 2025)
K244036 — Heel Incision Safety Lancet (SteriHeel 2) (February 26, 2025)
K233796 — Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disp (January 16, 2024)
K221521 — Disposable Safety Lancet (October 28, 2022)
K221970 — Lancing device (August 30, 2022)
K210745 — Heel Incision Safety Lancet (August 26, 2021)
K153706 — Insulin Pen Needle (August 29, 2016)

Other clearances for product code QRK

K250016 — droplet® personal lancets (July 1, 2025)
K244031 — Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposab (February 26, 2025)
K242622 — Sterile Lancets for Single Use (October 28, 2024)
K241810 — MICROLET®NEXT Lancet (August 15, 2024)
K232330 — Lancing System (January 4, 2024)
K230712 — SG Lanset I, SG Lancets, Soft Lancets (December 6, 2023)
K230310 — STAT Medical Device Lancing System (September 8, 2023)
K230759 — SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro (June 13, 2023)
K222617 — EasyTouch Lancing Device (March 21, 2023)
K223815 — ONE DROP Lancing Device (February 15, 2023)