Home / 510(k) Clearances / K221126

510(k) K221126

Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets by Owen Mumford, Ltd. — Product Code FMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2022
Date Received
April 18, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single Use Only Blood Lancet With 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, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.

Other clearances by Owen Mumford, Ltd.

  • K223854 — Unistik® ShieldLock, Unistik VacuFlip (June 30, 2023)
  • K231124 — Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), (June 27, 2023)
  • K222168 — Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and (November 3, 2022)
  • K222303 — Unistik® Pro (October 25, 2022)
  • K221613 — Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets (October 3, 2022)
  • K222111 — Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G (September 7, 2022)
  • K210399 — Unifine SafeControl (September 17, 2021)
  • K173881 — Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G (July 11, 2018)
  • K152339 — Unifine Pentips/ Unifine Pentips Plus (June 24, 2016)
  • K122837 — AUTOJECT 2 FOR GLASSY SYRINGE (October 15, 2012)

Other clearances for product code FMK

  • K253605 — Safety Heel Lancet (February 20, 2026)
  • K252490 — Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) (February 12, 2026)
  • K251694 — safety lancet (June 26, 2025)
  • K244036 — Heel Incision Safety Lancet (SteriHeel 2) (February 26, 2025)
  • K242680 — LetsGetChecked Impress (January 13, 2025)
  • K243533 — Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus (January 13, 2025)
  • K242664 — gentleheel® Adult Incision Device (November 5, 2024)
  • K242627 — Safety Lancet (October 30, 2024)
  • K242316 — Safety Lancet (August 28, 2024)
  • K241848 — MedtFine Safety Lancet (August 20, 2024)