510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K001162Substantially Equivalent

Goldfinger Device

Mali-Tech, Ltd., Ginot Shomron 44853, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001162 is the FDA 510(k) clearance record for GOLDFINGER DEVICE, a class II device, cleared for Mali-Tech , Ltd. on under FDA product code FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature). FDA's definition for product code FMK reads: "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...". FDA records list one 510(k) clearance for Mali-Tech , Ltd. As of , FDA records show no recalls naming K001162.

Clearance record

Decision date
Received
(121 days to decision)
Product code
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Regulation
21 CFR 878.4850
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Mali-Tech , Ltd. P.o.b. 454, Ginot Shomron 44853, IL
510(k) summary
Summary
Third party review
No

Clearances, product code FMK

Trailing 12 months
5 clearances under product code FMK in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FMK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260