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

Device class

Class II

Regulation 878.4850

Total clearances

2021-08-26 → 2026-05-01

Last 12 months

Unique sponsors

Definition

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

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.

Classification details

Medical specialty

General, Plastic Surgery

Review panel

Regulation number

878.4850

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Tianjin Huahong Technology Co., Ltd.	7	2	2026-03-31
Owen Mumford, Ltd.	5	0	2023-06-27
Ningbo Medsun Medical Co., Ltd.	4	1	2026-02-20
Roche Diabetes Care, Inc.	4	0	2023-11-13
SteriLance Medical (Suzhou), Inc.	4	0	2025-02-26
Promisemed Hangzhou Meditech Co., Ltd.	3	1	2026-05-01
Nsp Tech Pte, Ltd.	2	0	2022-10-24
Gri-Alleset, Inc.	2	0	2024-11-05
Medipurpose Pte. , Ltd.	1	0	2022-09-22
Becton, Dickinson and Company	1	0	2022-12-16
Yourbio Health, Inc.	1	0	2023-04-19
Suzhou Kyuan Medical Apparatus Co., Ltd.	1	0	2022-10-03
Asahi Polyslider Co., Ltd.	1	0	2022-11-02
Tasso, Inc.	1	0	2022-08-12
Ningbo Caremed Medical Products Co., Ltd.	1	0	2024-08-20
Huaian Hening Medical Instruments Co., Ltd.	1	0	2023-01-23
Drawbridge Health, Inc.	1	0	2024-02-22
Beijing Ruicheng Medical Supplies Co., Ltd.	1	0	2022-11-29
Medifun Corporation	1	0	2024-08-15
Facet Technologies, LLC	1	0	2023-02-13
Reddrop DX	1	0	2024-03-21
Sarstedt AG & CO KG	1	0	2023-01-25
Tianjin Rilifine Medical Device Co., Ltd.	1	0	2022-11-15
Hlb Co., Ltd. Healthcare	1	0	2025-01-13
Clinical Innovations, LLC	1	0	2023-02-24

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
A4259	HCPCS	Lancets, per box of 100 ✓ CMS-verified description	High	Blood lancet, single-use, for capillary blood sampling

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-01	K261045	Promisemed Hangzhou Meditech Co., Ltd.	Verifine Safety Lancets
2026-03-31	K260191	Tianjin Huahong Technology Co., Ltd.	Safety lancet (XXXVII)
2026-02-20	K253605	Ningbo Medsun Medical Co., Ltd.	Safety Heel Lancet
2026-02-12	K252490	Tianjin Huahong Technology Co., Ltd.	Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
2025-06-26	K251694	Tianjin Huahong Technology Co., Ltd.	safety lancet
2025-02-26	K244036	SteriLance Medical (Suzhou), Inc.	Heel Incision Safety Lancet (SteriHeel 2)
2025-01-13	K243533	Hlb Co., Ltd. Healthcare	Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus
2025-01-13	K242680	Privapath Diagnostics Ltd (Dba Letsgetchecked)	LetsGetChecked Impress
2024-11-05	K242664	Gri-Alleset, Inc.	gentleheel® Adult Incision Device
2024-10-30	K242627	Ningbo Medsun Medical Co., Ltd.	Safety Lancet
2024-08-28	K242316	Ningbo Medsun Medical Co., Ltd.	Safety Lancet
2024-08-20	K241848	Ningbo Caremed Medical Products Co., Ltd.	MedtFine Safety Lancet
2024-08-15	K241750	Medifun Corporation	Medifun Safety Lancet ( MSL1 series)
2024-06-20	K241627	Tianjin Huahong Technology Co., Ltd.	Safety Lancet (XXXV)
2024-05-21	K240806	Tianjin Huahong Technology Co., Ltd.	Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
2024-03-21	K234081	Reddrop DX	RedDrop ONE (One)
2024-02-22	K223826	Drawbridge Health, Inc.	NanoDrop Lancet
2024-01-16	K233796	SteriLance Medical (Suzhou), Inc.	Disposable safety lancet (Impress); Disposable safety lancet (Impress Pro); Disposable safety lancet (Lite4); Disposable blood lancet (Elite); Disposable blood lancet (Elite Pro)
2023-11-13	K232509	Roche Diabetes Care, Inc.	Accu-Chek Safe-T-Pro Uno Lancing Device
2023-11-13	K232488	Roche Diabetes Care, Inc.	Accu-Chek Safe-T-Pro Plus Lancing Device
2023-06-27	K231124	Owen Mumford, Ltd.	Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)
2023-04-19	K223201	Yourbio Health, Inc.	TAP Lancet
2023-03-02	K223352	Accriva Diagnostics, Inc.	Tenderfoot
2023-02-24	K223900	Clinical Innovations, LLC	babyLance Safety Heelstick (BLM, BLN, BLP)
2023-02-13	K223370	Facet Technologies, LLC	NeatNick Heel Safety Lancet