510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250016Substantially Equivalent

droplet® personal lancets

HTL-Strefa S.A., Ozorków, PL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K250016 is the FDA 510(k) clearance record for droplet® personal lancets, a class II device, cleared for Htl-Strefa S.A on under FDA product code QRK (Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature). FDA's definition for product code QRK reads: "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". FDA records list 8 510(k) clearances for Htl-Strefa S.A, from to . As of , FDA records show no recalls naming K250016.

Clearance record

Decision date
Received
(179 days to decision)
Product code
QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Regulation
21 CFR 878.4850
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Htl-Strefa S.A Adamówek 7, Ozorków, PL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QRK

Trailing 12 months
2 clearances under product code QRK in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QRK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20261
September 20260
October 20260