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FDA 510(k)

droplet® personal lancets

K-Number: K250016 · 2025-07-01

ApplicantHtl-Strefa S.A
Decision Date2025-07-01
Product CodeQRK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

droplet® personal lancets is a medical device manufactured by Htl-Strefa S.A. It received FDA 510(k) clearance on 2025-07-01 under approval number K250016. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the droplet® personal lancets?

droplet® personal lancets is a medical device that received FDA 510(k) clearance on 2025-07-01. It is manufactured by Htl-Strefa S.A. The 510(k) number is K250016.

When was droplet® personal lancets approved by the FDA?

droplet® personal lancets received FDA 510(k) clearance on 2025-07-01, under approval number K250016.

What company makes droplet® personal lancets?

droplet® personal lancets is manufactured by Htl-Strefa S.A.

What is the FDA product code for droplet® personal lancets?

The FDA product code for droplet® personal lancets is QRK.

Other Devices by Htl-Strefa S.A

K170988DropSafe Safety Pen Needle K171982DROPLET PEN NEEDLE K202340Droplet Pen Needle 30G & 33G K192082Droplet Pen Needle 34G K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets

Related Devices (Code: QRK)

K221383MedtFine Blood LancetShanghai Carelife International Trading Co. , Ltd. K221507Disposable Blood LancetSteriLance Medical (Suzhou), Inc. K221433Facet 28G Universal LancetFacet Technologies, LLC K230712SG Lanset I, SG Lancets, Soft LancetsSewon Medical Co. K230310STAT Medical Device Lancing SystemStat Medical Devices K230759SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)Bosungmeditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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