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

Multiple Use Blood Lancet For Single Patient Use Only

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

QRL is the FDA product code for Multiple Use Blood Lancet For Single Patient Use Only, a class II device type, regulated under 21 CFR 878.4850. FDA's definition for this code reads: "A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes". As of , FDA records hold 27 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
QRL
Device name
Multiple Use Blood Lancet For Single Patient Use Only
FDA definition
A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable 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
27
Ingested recalls
1

Clearances, product code QRL

By decision year
27 clearances under product code QRL with a decision year between 2022 and 2026, 2022 the highest year at 17.
Show the numbers
510(k) clearances under FDA product code QRL by decision year
YearClearances
202217
20233
20242
20252
20263

Applicants with the most clearances

Product code QRL
Applicants holding the most 510(k) clearances under product code QRL
ApplicantClearances
Tianjin Huahong Technology Co., Ltd.4
Facet Technologies, LLC.3
Medrad, Inc.2
Roche Diabetes Care, Inc.2
Sterilance Medical (Suzhou) Inc.2
Arkray, Inc.1
Asahi Polyslider Co., Ltd.1
Beijing Ruicheng Medical Supplies Co., Ltd.1
Bionime Corporation1
Gostar Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 83 companies shown, in name order