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

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

21 CFR 878.4850 / General, Plastic Surgery
FDA source (opens on fda.gov)

QRK is the FDA product code for Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, a class II device type, regulated under 21 CFR 878.4850. FDA's definition for this code 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". As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QRK
Device name
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
FDA definition
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.
Regulation
21 CFR 878.4850
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
17
Ingested recalls
0

Clearances, product code QRK

By decision year
17 clearances under product code QRK with a decision year between 2022 and 2026, 2023 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code QRK by decision year
YearClearances
20223
20237
20243
20252
20262

Applicants with the most clearances

Product code QRK
Applicants holding the most 510(k) clearances under product code QRK
ApplicantClearances
Stat Medical Devices, Inc.3
Sterilance Medical (Suzhou) Inc.3
Medrad, Inc.1
Bosungmeditech Co., Ltd.1
Facet Technologies, LLC.1
HTL-Strefa S.A.1
Huaian Hening Medical Instruments Co., Ltd.1
MEDIPOINT Holdings, LLC1
Ningbo Caremed Medical Products Co Ltd1
Ningbo Medsun Medical Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 79 companies shown, in name order