Product Code: FMK FDA class 2 21 CFR 878.4850

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

General, Plastic Surgery

A single-use blood lancet with an integral sharps injury prevention feature is a disposable device consisting of a single-use blade on a non-reusable base, used to puncture the skin to obtain a small blood sample for diagnostic purposes. The integral sharps injury prevention feature renders the device inoperable after a single use, preventing needlestick injuries. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FMK, regulated under 21 CFR 878.4850 in the General and Plastic Surgery specialty.

View on FDA

510(k)s

110

FEI Numbers

157

Registration Numbers

157

Unique Applicants

Years Active

Research product code FMK in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: FMK
Device Class: FDA class 2
Regulation Number: 878.4850
Medical Specialty: General, Plastic Surgery
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

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.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 110 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261045	Verifine Safety Lancets	May 01, 2026	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K260191	Safety lancet (XXXVII)	Mar 31, 2026	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.
K253605	Safety Heel Lancet	Feb 20, 2026	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.
K252490	Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)	Feb 12, 2026	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.
K251694	safety lancet	Jun 26, 2025	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.
K244036	Heel Incision Safety Lancet (SteriHeel 2)	Feb 26, 2025	Substantially Equivalent	SteriLance Medical (Suzhou), Inc.
K243533	Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus	Jan 13, 2025	Substantially Equivalent	Hlb Co., Ltd. Healthcare
K242680	LetsGetChecked Impress	Jan 13, 2025	Unknown	Privapath Diagnostics Ltd (Dba Letsgetchecked)
K242664	gentleheel® Adult Incision Device	Nov 05, 2024	Substantially Equivalent	Gri-Alleset, Inc.
K242627	Safety Lancet	Oct 30, 2024	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.
K242316	Safety Lancet	Aug 28, 2024	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.
K241848	MedtFine Safety Lancet	Aug 20, 2024	Substantially Equivalent	Ningbo Caremed Medical Products Co., Ltd.
K241750	Medifun Safety Lancet ( MSL1 series)	Aug 15, 2024	Substantially Equivalent	Medifun Corporation
K241627	Safety Lancet (XXXV)	Jun 20, 2024	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.
K240806	Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)	May 21, 2024	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.
K234081	RedDrop ONE (One)	Mar 21, 2024	Unknown	Reddrop DX
K223826	NanoDrop Lancet	Feb 22, 2024	Substantially Equivalent	Drawbridge Health, Inc.
K233796	Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)	Jan 16, 2024	Substantially Equivalent	SteriLance Medical (Suzhou), Inc.
K232509	Accu-Chek Safe-T-Pro Uno Lancing Device	Nov 13, 2023	Substantially Equivalent	Roche Diabetes Care, Inc.
K232488	Accu-Chek Safe-T-Pro Plus Lancing Device	Nov 13, 2023	Substantially Equivalent	Roche Diabetes Care, Inc.
K231124	Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)	Jun 27, 2023	Substantially Equivalent	Owen Mumford, Ltd.
K223201	TAP Lancet	Apr 19, 2023	Unknown	Yourbio Health, Inc.
K223352	Tenderfoot	Mar 02, 2023	Substantially Equivalent	Accriva Diagnostics, Inc.
K223900	babyLance Safety Heelstick (BLM, BLN, BLP)	Feb 24, 2023	Substantially Equivalent	Clinical Innovations, LLC
K223370	NeatNick Heel Safety Lancet	Feb 13, 2023	Substantially Equivalent	Facet Technologies, LLC
K223208	Safety Lancet	Feb 10, 2023	Substantially Equivalent	Suzhou Zhenwu Medical Co., Ltd.
K222801	Safety Lancet	Jan 25, 2023	Substantially Equivalent	Sarstedt AG & CO KG
K223313	Disposable Safety Lancets	Jan 23, 2023	Substantially Equivalent	Huaian Hening Medical Instruments Co., Ltd.
K223243	BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel Lancets	Dec 16, 2022	Substantially Equivalent	Becton, Dickinson and Company
K222408	Disposable Safety Lancet	Nov 29, 2022	Substantially Equivalent	Beijing Ruicheng Medical Supplies Co., Ltd.
K222055	Disposable Sterile Lancet	Nov 15, 2022	Substantially Equivalent	Tianjin Rilifine Medical Device Co., Ltd.
K222168	Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler	Nov 03, 2022	Substantially Equivalent	Owen Mumford, Ltd.
K222084	OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie	Nov 02, 2022	Substantially Equivalent	Asahi Polyslider Co., Ltd.
K221521	Disposable Safety Lancet	Oct 28, 2022	Substantially Equivalent	SteriLance Medical (Suzhou), Inc.
K222303	Unistik® Pro	Oct 25, 2022	Substantially Equivalent	Owen Mumford, Ltd.
K221783	SafetiCET Safety Lancet	Oct 24, 2022	Substantially Equivalent	Nsp Tech Pte, Ltd.
K222376	Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)	Oct 03, 2022	Substantially Equivalent	Shandong Lianfa Medical Plastic Products Co. , Ltd.
K221778	Disposable Safety Lancets	Oct 03, 2022	Substantially Equivalent	Suzhou Kyuan Medical Apparatus Co., Ltd.
K222090	Safety Lancet	Sep 30, 2022	Substantially Equivalent	Ningbo Medsun Medical Co., Ltd.
K222224	SurgiLance® Safety Lancet	Sep 22, 2022	Substantially Equivalent	Medipurpose Pte. , Ltd.
K221839	Lancet	Sep 19, 2022	Substantially Equivalent	Hebei Xinle Sci&Tech Co., Ltd.
K222111	Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G	Sep 07, 2022	Substantially Equivalent	Owen Mumford, Ltd.
K221604	SafetiHeel, MediHeel, Novaplus	Aug 22, 2022	Substantially Equivalent	Nsp Tech Pte, Ltd.
K221131	Tasso+	Aug 12, 2022	Substantially Equivalent	Tasso, Inc.
K221126	Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets	Aug 12, 2022	Substantially Equivalent	Owen Mumford, Ltd.
K220643	DropSafe Acti-Lance Safety Lancets; droplet ACTI-LANCE Safety Lancets, DropSafe Medlance Plus Safety Lancets; droplet MEDLANCE PLUS Safety Lancets, DropSafe ergoLance Safety Lancets, DropSafe Prolance Safety Lancets, DropSafe Medisafe Solo Safety Lancets; DropSafe Haemolance Plus Safety Lancets	Jul 08, 2022	Substantially Equivalent	Htl-Strefa S.A
K221368	Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet	Jun 09, 2022	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K221371	Promisemed Heel Blood Lancet	Jun 08, 2022	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K220849	Accu-Chek Safe-T-Pro Plus Lancing Device	May 19, 2022	Substantially Equivalent	Roche Diabetes Care, Inc.
K220370	Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI)	May 19, 2022	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.
K220917	gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler	May 18, 2022	Substantially Equivalent	Gri-Alleset, Inc.
K220372	Heel Stick Safety Lancet (HHZ-II, HHZ-III)	May 17, 2022	Substantially Equivalent	Tianjin Huahong Technology Co., Ltd.
K220364	Accu-Chek Safe-T-Pro Uno Lancing Device	Apr 05, 2022	Substantially Equivalent	Roche Diabetes Care, Inc.
K210745	Heel Incision Safety Lancet	Aug 26, 2021	Substantially Equivalent	SteriLance Medical (Suzhou), Inc.
K193009	Promisemed Heel Blood Lancet	Dec 03, 2019	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K192666	Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet	Dec 02, 2019	Substantially Equivalent	Promisemed Hangzhou Meditech Co., Ltd.
K172712	gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler	Nov 06, 2017	Substantially Equivalent	Gri Medical & Electronic Technology Co., Ltd.
K153670	Genteel Lancing Device	May 12, 2016	Substantially Equivalent	Genteel, LLC
K130132	BABYLANCE HEEL INCISION DEVICE	Feb 11, 2013	Substantially Equivalent	Medipurpose Pte. , Ltd.
K113513	PLANCET	Jul 13, 2012	Substantially Equivalent	Micropoint Technologies Pte, Ltd.
K113332	ON CALL CHOSEN LANCING DEVICE	Apr 18, 2012	Substantially Equivalent	ACON Laboratories, Inc.
K101145	SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250	Oct 21, 2010	Substantially Equivalent	Medipurpose Pte. , Ltd.
K101417	BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200	Oct 19, 2010	Substantially Equivalent	Medipurpose Pte. , Ltd.
K041665	L1-PRO SYSTEM	Jul 23, 2004	Substantially Equivalent	Pelikan Technologies, Inc.
K024170	L1 SYSTEM	Apr 14, 2003	Substantially Equivalent	Pelikan Technologies, Inc.
K001162	GOLDFINGER DEVICE	Aug 09, 2000	Substantially Equivalent	Mali-Tech , Ltd.
K944948	FREE-LANCE	Nov 17, 1994	Substantially Equivalent	F.F.F. Enterprises, Inc.
K942548	JENNINGS JAVELIN	Nov 03, 1994	Substantially Equivalent	Jfi Endineering, Inc.
K942620	FEATHER-TOUCH SINGLE-STICK DEVICE	Jun 22, 1994	Substantially Equivalent	Ulster Scientific, Inc.
K931258	SOFTTOUCH II LANCET DEVICE	Feb 10, 1994	Substantially Equivalent	Boehringer Mannheim Corp.
K933365	BABISTICK	Oct 19, 1993	Substantially Equivalent	Graphic Controls Corp.
K931828	CARELET SAFETY LANCET	Oct 15, 1993	Substantially Equivalent	Gainor Medical Europe, Ltd.
K931481	MINI-LANCET	Oct 01, 1993	Substantially Equivalent	Pacific Rim Products, Inc.
K932785	MONOJECT(R) MONOLETTOR SAFETY LANCET	Sep 29, 1993	Substantially Equivalent	Sherwood Medical Co.
K931827	CLEANLET, CLEANLET XL & KIDS	Sep 13, 1993	Substantially Equivalent	Gainor Medical Europe, Ltd.
K932725	B-D ULTRA FINE(R) LANCET	Jul 23, 1993	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K923302	TENDERLETT FINGER	Jan 22, 1993	Substantially Equivalent	International Technidyne Corp.
K920562	UNISTIK	Mar 27, 1992	Substantially Equivalent	Ulster Scientific, Inc.
K911997	TENDERFOOT(R), MODIFICATION	Jul 17, 1991	Substantially Equivalent	International Technidyne Corp.
K902430	GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD	Aug 02, 1990	Substantially Equivalent	Heraeus Kulzer, Inc.
K902416	SURELITE AND SURELITE XL BLOOD LANCET	Aug 01, 1990	Substantially Equivalent	Gainor Medical Europe, Ltd.
K894427	DISPOSABLE IV INDUCTION COVER	Sep 11, 1989	Substantially Equivalent	Central Plastic, Inc.
K894474	THE AUTOLET LITE	Aug 18, 1989	Substantially Equivalent	Ulster Scientific, Inc.
K885342	GENNY DENNY IV SHIELD	Mar 30, 1989	Substantially Equivalent	Mercury Enterprises, Inc.
K883968	TENDERFOOT	Dec 01, 1988	Substantially Equivalent	International Technidyne Corp.
K883957	ARTERIAL ANCHOR BANDAGE	Oct 18, 1988	Substantially Equivalent	Guidelines, Inc.
K883420	LANCET, BLOOD	Aug 26, 1988	Substantially Equivalent	Primrose Medical, Inc.
K880869	MEDI-LET	Mar 21, 1988	Substantially Equivalent	Medicore, Inc.
K850100	BLOOD LANCET	Jan 29, 1987	Substantially Equivalent	Gainor Medical
K870017	AMG + MED LANCET	Jan 21, 1987	Substantially Equivalent	Can-Am Surgical Corp.
K865016	BLOOD LANCET	Jan 12, 1987	Substantially Equivalent	Falcon Medical Industries, Inc.
K863621	PALS	Oct 06, 1986	Substantially Equivalent	West Lake Marketing
K861265	DIALET LANCING DEVICE	Apr 30, 1986	Substantially Equivalent	Home Diagnostics, Inc.
K861243	NEONATAL UNILET	Apr 29, 1986	Substantially Equivalent	Ulster Scientific, Inc.
K861151	SUEL BLOOD LANCET	Apr 15, 1986	Substantially Equivalent	Exel Intl.
K855203	GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD	Feb 11, 1986	Substantially Equivalent	Miles Laboratories, Inc.
K854760	CHURCHHILL LANCET	Jan 03, 1986	Substantially Equivalent	Churchill Corp.
K850150	ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED	Feb 21, 1985	Substantially Equivalent	Gainor Medical
K841677	STERILE BLOOD LANCETS	Jun 11, 1984	Substantially Equivalent	Abco Dealers, Inc.
K833816	HEMASTICK 1-1.5 & 2-DISPOS. BLOOD	Dec 22, 1983	Substantially Equivalent	Medprobe Laboratories
K833812	SUPERJET DISPOSABLE BLOOD LANCET	Dec 12, 1983	Substantially Equivalent	Medrobe Laboratories
K833344	AUTO-LANCET	Nov 07, 1983	Substantially Equivalent	Palco Laboratories, Inc.
K830001	SUPERJET BTD BLEEDING TIME DEVICE DISP	Sep 26, 1983	Substantially Equivalent	Medprobe Laboratories
K830010	SUPERJET LANCET	Jan 26, 1983	Substantially Equivalent	Medprobe Laboratories
K823760	PRICK-TEST NEEDLE	Jan 14, 1983	Substantially Equivalent	Cordis Corp.
K822209	AUTOLANCET	Aug 27, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K820625	HEMALET AUTOMATIC LANCET DEVICE	Apr 09, 1982	Substantially Equivalent	Medprobe Laboratories
K820333	MONOJECTOR MONOLET LANCER	Mar 10, 1982	Substantially Equivalent	Sherwood Medical Co.
K810681	MEDI-LANCE	Mar 26, 1981	Substantially Equivalent	Medicore, Inc.
K810075	AUTOCLIX	Feb 04, 1981	Substantially Equivalent	Biodynamics Corp.