droplet® personal lancets— 510(k) K250016

Substantially Equivalent

Htl-Strefa S.A

FDA 510(k) clearance K250016 for droplet® personal lancets, Substantially Equivalent on 2025-07-01. Applicant: Htl-Strefa S.A. Device class: 2.

Clearance details

Applicant: Htl-Strefa S.A
Product code: Code QRK
Device class: Class 2
Regulation: 21 CFR 878.4850
Advisory panel: General, Plastic Surgery
Date received: 2025-01-03
Decision date: 2025-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ozorków, PL

Download summary PDF View on FDA.gov ↗

Recent devices under product code QRK

K262631 — Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)2026-08-25
K261634 — Disposable Blood Lancet (Soft)2026-06-12
K244031 — Disposable Blood Lancet (4 models)2025-02-26
K242622 — Sterile Lancets for Single Use2024-10-28
K241810 — MICROLET®NEXT Lancet2024-08-15

More clearances from Htl-Strefa S.A

K220643 — DropSafe Acti-Lance Safety Lancets +3 more2022-07-08
K202340 — Droplet Pen Needle 30G & 33G2020-10-15
K192082 — Droplet Pen Needle 34G2020-04-21
K171982 — DROPLET PEN NEEDLE2018-03-21
K170988 — DropSafe Safety Pen Needle2017-12-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.