QRK · Class II · 21 CFR 878.4850

FDA Product Code QRK: Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

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.

Leading manufacturers include Stat Medical Devices, SteriLance Medical (Suzhou), Inc. and Shanghai Carelife International Trading Co. , Ltd..

16
Total
16
Cleared
112d
Avg days
2022
Since
Declining activity - 5 submissions in the last 2 years vs 11 in the prior period
Review times improving: avg 74d recently vs 129d historically

FDA 510(k) Cleared Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature Devices (Product Code QRK)

16 devices
1–16 of 16
Cleared Jul 01, 2025
droplet® personal lancets
K250016
Htl-Strefa S.A
General & Plastic Surgery · 179d
Cleared Feb 26, 2025
Disposable Blood Lancet (Soft Pro)
K244031
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 58d
Cleared Oct 28, 2024
Sterile Lancets for Single Use
K242622
Ningbo Caremed Medical Products Co., Ltd.
General & Plastic Surgery · 55d
Cleared Aug 15, 2024
MICROLET®NEXT Lancet
K241810
Ascensia Diabetes Care U.S., Inc.
General & Plastic Surgery · 55d
Cleared Jan 04, 2024
Lancing System
K232330
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 154d
Cleared Dec 06, 2023
SG Lanset I, SG Lancets, Soft Lancets
K230712
Sewon Medical Co.
General & Plastic Surgery · 266d
Cleared Sep 08, 2023
STAT Medical Device Lancing System
K230310
Stat Medical Devices
General & Plastic Surgery · 217d
Cleared Jun 13, 2023
SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
K230759
Bosungmeditech Co., Ltd.
General & Plastic Surgery · 85d
Cleared Mar 21, 2023
EasyTouch Lancing Device
K222617
Stat Medical Devices
General & Plastic Surgery · 203d
Cleared Feb 15, 2023
ONE DROP Lancing Device
K223815
Stat Medical Devices
General & Plastic Surgery · 57d
Cleared Jan 25, 2023
Disposable Blood Lancets
K223314
Huaian Hening Medical Instruments Co., Ltd.
General & Plastic Surgery · 89d
Cleared Jan 13, 2023
Medipoint Blood Lancets
K223480
Medipoint Holdings, LLC
General & Plastic Surgery · 56d
Cleared Sep 21, 2022
MedtFine Blood Lancet
K221383
Shanghai Carelife International Trading Co. , Ltd.
General & Plastic Surgery · 131d
Cleared Aug 31, 2022
Disposable Blood Lancet
K221507
SteriLance Medical (Suzhou), Inc.
General & Plastic Surgery · 100d
Cleared Jul 15, 2022
Facet 28G Universal Lancet
K221433
Facet Technologies, LLC
General & Plastic Surgery · 59d

About Product Code QRK - Regulatory Context

510(k) Submission Activity

16 total 510(k) submissions under product code QRK since 2022, with 16 receiving FDA clearance (average review time: 112 days).

Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 11 in the prior period.

FDA 510(k) Review Time - QRK Product Code

Recent submissions under QRK have taken an average of 74 days to reach a decision - down from 129 days historically, suggesting improved FDA processing for this classification.

QRK devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →