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510(k) K223352

Tenderfoot by Accriva Diagnostics, Inc. — Product Code FMK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 2, 2023
Date Received
November 2, 2022
Clearance Type
Special
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 Accriva Diagnostics, Inc.

  • K202101 — GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (A (December 29, 2021)
  • K193041 — Hemochron Signature Elite (November 22, 2019)

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)