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

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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

FMK is the FDA product code for Single Use Only Blood Lancet With 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, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature...". As of , FDA records hold 110 510(k) clearances under this code, the most recent dated , and 17 recalls.

Classification record

Product code
FMK
Device name
Single Use Only Blood Lancet With 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, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.
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
111
Ingested recalls
17

Clearances, product code FMK

By decision year
111 clearances under product code FMK with a decision year between 1981 and 2026, 2022 the highest year at 25.
Show the numbers
510(k) clearances under FDA product code FMK by decision year
YearClearances
19812
19823
19836
19841
19851
19866
19873
19884
19893
19902
19911
19921
19937
19944
20001
20031
20041
20102
20122
20131
20161
20171
20192
20211
202225
202310
202410
20254
20265

Applicants with the most clearances

Product code FMK
Applicants holding the most 510(k) clearances under product code FMK
ApplicantClearances
Tianjin Huahong Technology Co., Ltd.7
Owen Mumford Limited5
Promisemed Hangzhou Meditech Co.,Ltd.5
Accriva Diagnostics, Inc.4
Medipurpose Pte. Ltd.4
Medprobe Laboratories4
Ningbo Medsun Medical Co., Ltd.4
Roche Diabetes Care, Inc.4
Sterilance Medical (Suzhou) Inc.4
Ulster Scientific, Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 154 companies shown, in name order