ClearanceBrief
Panels › General, Plastic Surgery › Product code FMK · Class 2

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

Regulation 878.4850

5510(k)s in 12 months (111 all time)
0recalls in 12 months (17 all time)
1recalls that name a 510(k)
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Top companies in FMK

Company510(k)sRecalls
Tianjin Huahong Technology Co., Ltd.80
Owen Mumford, Ltd.50
Promisemed Hangzhou Meditech Co., Ltd.50
Cardinal Health Inc.04
International Technidyne Corp.31
Medipurpose Pte. , Ltd.40
Medprobe Laboratories40
Ningbo Medsun Medical Co., Ltd.40
Roche Diabetes Care, Inc.40
SteriLance Medical (Suzhou), Inc.40
Decided510(k)Device and applicantCode
Sep 13, 2026K262526Safety lancet (XL)
Tianjin Huahong Technology Co., Ltd., CN
FMK
May 1, 2026K261045Verifine Safety Lancets
Promisemed Hangzhou Meditech Co., Ltd., CN
FMK
Mar 31, 2026K260191Safety lancet (XXXVII)
Tianjin Huahong Technology Co., Ltd., CN
FMK
Feb 20, 2026K253605Safety Heel Lancet
Ningbo Medsun Medical Co., Ltd., CN
FMK
Feb 12, 2026K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
Tianjin Huahong Technology Co., Ltd., CN
FMK
Jun 26, 2025K251694safety lancet
Tianjin Huahong Technology Co., Ltd., CN
FMK
Feb 26, 2025K244036Heel Incision Safety Lancet (SteriHeel 2)
SteriLance Medical (Suzhou), Inc., CN
FMK
Jan 13, 2025K243533Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
Hlb Co., Ltd. Healthcare, KR
FMK
Jan 13, 2025K242680LetsGetChecked Impress
Privapath Diagnostics Ltd (Dba Letsgetchecked), IE
FMK
Nov 5, 2024K242664gentleheel® Adult Incision Device
Gri-Alleset, Inc.
FMK
Oct 30, 2024K242627Safety Lancet
Ningbo Medsun Medical Co., Ltd., CN
FMK
Aug 28, 2024K242316Safety Lancet
Ningbo Medsun Medical Co., Ltd., CN
FMK
Aug 20, 2024K241848MedtFine Safety Lancet
Ningbo Caremed Medical Products Co., Ltd., CN
FMK
Aug 15, 2024K241750Medifun Safety Lancet ( MSL1 series)
Medifun Corporation, TW
FMK
Jun 20, 2024K241627Safety Lancet (XXXV)
Tianjin Huahong Technology Co., Ltd., CN
FMK
May 21, 2024K240806Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
Tianjin Huahong Technology Co., Ltd., CN
FMK
Mar 21, 2024K234081RedDrop ONE (One)
Reddrop DX
FMK
Feb 22, 2024K223826NanoDrop Lancet
Drawbridge Health, Inc.
FMK
Jan 16, 2024K233796Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable
SteriLance Medical (Suzhou), Inc., CN
FMK
Nov 13, 2023K232509Accu-Chek Safe-T-Pro Uno Lancing Device
Roche Diabetes Care, Inc.
FMK
Nov 13, 2023K232488Accu-Chek Safe-T-Pro Plus Lancing Device
Roche Diabetes Care, Inc.
FMK
Jun 27, 2023K231124Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
Owen Mumford, Ltd., GB
FMK
Apr 19, 2023K223201TAP Lancet
Yourbio Health, Inc.
FMK
Mar 2, 2023K223352Tenderfoot
Accriva Diagnostics, Inc.
FMK
Feb 24, 2023K223900babyLance Safety Heelstick (BLM, BLN, BLP)
Clinical Innovations, LLC
FMK
Feb 13, 2023K223370NeatNick Heel Safety Lancet
Facet Technologies, LLC
FMK
Feb 10, 2023K223208Safety Lancet
Suzhou Zhenwu Medical Co., Ltd., CN
FMK
Jan 25, 2023K222801Safety Lancet
Sarstedt AG & CO KG, DE
FMK
Jan 23, 2023K223313Disposable Safety Lancets
Huaian Hening Medical Instruments Co., Ltd., CN
FMK
Dec 16, 2022K223243BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets
Becton, Dickinson and Company
FMK
Nov 29, 2022K222408Disposable Safety Lancet
Beijing Ruicheng Medical Supplies Co., Ltd., CN
FMK
Nov 15, 2022K222055Disposable Sterile Lancet
Tianjin Rilifine Medical Device Co., Ltd., CN
FMK
Nov 3, 2022K222168Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Sing
Owen Mumford, Ltd., GB
FMK
Nov 2, 2022K222084OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet N
Asahi Polyslider Co., Ltd., JP
FMK
Oct 28, 2022K221521Disposable Safety Lancet
SteriLance Medical (Suzhou), Inc., CN
FMK
Oct 25, 2022K222303Unistik® Pro
Owen Mumford, Ltd., GB
FMK
Oct 24, 2022K221783SafetiCET Safety Lancet
Nsp Tech Pte, Ltd., SG
FMK
Oct 3, 2022K222376Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
Shandong Lianfa Medical Plastic Products Co. , Ltd., CN
FMK
Oct 3, 2022K221778Disposable Safety Lancets
Suzhou Kyuan Medical Apparatus Co., Ltd., CN
FMK
Sep 30, 2022K222090Safety Lancet
Ningbo Medsun Medical Co., Ltd., CN
FMK
Sep 22, 2022K222224SurgiLance® Safety Lancet
Medipurpose Pte. , Ltd., SG
FMK
Sep 19, 2022K221839Lancet
Hebei Xinle Sci&Tech Co., Ltd., CN
FMK
Sep 7, 2022K222111Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G
Owen Mumford, Ltd., GB
FMK
Aug 22, 2022K221604SafetiHeel, MediHeel, Novaplus
Nsp Tech Pte, Ltd., SG
FMK
Aug 12, 2022K221131Tasso+
Tasso, Inc.
FMK
Aug 12, 2022K221126Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile si
Owen Mumford, Ltd., GB
FMK
Jul 8, 2022K220643DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet ME
Htl-Strefa S.A, PL
FMK
Jun 9, 2022K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet
Promisemed Hangzhou Meditech Co., Ltd., CN
FMK
Jun 8, 2022K221371Promisemed Heel Blood Lancet
Promisemed Hangzhou Meditech Co., Ltd., CN
FMK
May 19, 2022K220849Accu-Chek Safe-T-Pro Plus Lancing Device
Roche Diabetes Care, Inc.
FMK

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