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QRK · Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

General, Plastic Surgery · 16 clearances · 12 unique sponsors

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Device class

Class II

Regulation 878.4850

Total clearances

2022-07-15 → 2026-06-12

Last 12 months

Unique sponsors

Definition

What is Single Use Only Blood Lancet Without 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, nonreusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.

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
Stat Medical Devices	3	0	2023-09-08
SteriLance Medical (Suzhou), Inc.	3	1	2026-06-12
Huaian Hening Medical Instruments Co., Ltd.	1	0	2023-01-25
Ascensia Diabetes Care U.S., Inc.	1	0	2024-08-15
Sewon Medical Co.	1	0	2023-12-06
Facet Technologies, LLC	1	0	2022-07-15
Shanghai Carelife International Trading Co. , Ltd.	1	0	2022-09-21
Medipoint Holdings, LLC	1	0	2023-01-13
Bosungmeditech Co., Ltd.	1	0	2023-06-13
Ningbo Medsun Medical Co., Ltd.	1	0	2024-01-04
Htl-Strefa S.A	1	0	2025-07-01
Ningbo Caremed Medical Products Co., Ltd.	1	0	2024-10-28

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
A4651	HCPCS	Calibrated microcapillary tube, each ✓ CMS-verified description	High	Lancing device (dialysis), each; blood lancet for skin puncture
36415	CPT	—	Medium	Venipuncture; collection of blood sample using lancet

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-06-12	K261634	SteriLance Medical (Suzhou), Inc.	Disposable Blood Lancet (Soft)
2025-07-01	K250016	Htl-Strefa S.A	droplet® personal lancets
2025-02-26	K244031	SteriLance Medical (Suzhou), Inc.	Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood Lancet (Softsure Pro); Disposable Blood Lancet (Softsense)
2024-10-28	K242622	Ningbo Caremed Medical Products Co., Ltd.	Sterile Lancets for Single Use
2024-08-15	K241810	Ascensia Diabetes Care U.S., Inc.	MICROLET®NEXT Lancet
2024-01-04	K232330	Ningbo Medsun Medical Co., Ltd.	Lancing System
2023-12-06	K230712	Sewon Medical Co.	SG Lanset I, SG Lancets, Soft Lancets
2023-09-08	K230310	Stat Medical Devices	STAT Medical Device Lancing System
2023-06-13	K230759	Bosungmeditech Co., Ltd.	SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)
2023-03-21	K222617	Stat Medical Devices	EasyTouch Lancing Device
2023-02-15	K223815	Stat Medical Devices	ONE DROP Lancing Device
2023-01-25	K223314	Huaian Hening Medical Instruments Co., Ltd.	Disposable Blood Lancets
2023-01-13	K223480	Medipoint Holdings, LLC	Medipoint Blood Lancets
2022-09-21	K221383	Shanghai Carelife International Trading Co. , Ltd.	MedtFine Blood Lancet
2022-08-31	K221507	SteriLance Medical (Suzhou), Inc.	Disposable Blood Lancet
2022-07-15	K221433	Facet Technologies, LLC	Facet 28G Universal Lancet