EasyTouch Lancing Device

Q: What is the product code of K222617?

The FDA product code is QRK – Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, a Class II (moderate risk) device regulated under 21 CFR 878.4850.

FDA 510(k) K222617 · Stat Medical Devices

Substantially Equivalent

510(k) numberK222617

Submission

Device name: EasyTouch Lancing Device
Applicant: Stat Medical Devices
North Miami Beach, FL, US
Received: August 30, 2022
Decision date: March 21, 2023
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QRK – Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4850
Specialty: General, Plastic Surgery

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.

Other 510(k)s with product code QRK

510(k)	Device	Applicant	Decision
K262631	Disposable blood lancet (Soft Pro, Softsure, Softsure Pro, Softsense)QRK · Special	SteriLance Medical (Suzhou), Inc.	08/25/2026SE
K261634	Disposable Blood Lancet (Soft)QRK · Special	SteriLance Medical (Suzhou), Inc.	06/12/2026SE
K250016	droplet® personal lancetsQRK · Traditional	Htl-Strefa S.A	07/01/2025SE
K244031	Disposable Blood Lancet (Soft Pro); Disposable Blood Lancet (Softsure); Disposable Blood…QRK · Traditional	SteriLance Medical (Suzhou), Inc.	02/26/2025SE
K242622	Sterile Lancets for Single UseQRK · Traditional	Ningbo Caremed Medical Products Co., Ltd.	10/28/2024SE
K241810	MICROLET®NEXT LancetQRK · Traditional	Ascensia Diabetes Care U.S., Inc.	08/15/2024SE
K232330	Lancing SystemQRK · Traditional	Ningbo Medsun Medical Co., Ltd.	01/04/2024SE
K230712	SG Lanset I, SG Lancets, Soft LancetsQRK · Traditional	Sewon Medical Co.	12/06/2023SE
K230310	STAT Medical Device Lancing SystemQRK · Traditional	Stat Medical Devices	09/08/2023SE
K230759	SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro)QRK · Traditional	Bosungmeditech Co., Ltd.	06/13/2023SE

More from Bosungmeditech Co., Ltd.

510(k)	Device	Decision
K230310	STAT Medical Device Lancing SystemQRK · Traditional	09/08/2023SE
K223815	ONE DROP Lancing DeviceQRK · Traditional	02/15/2023SE
K092016	Super-Fine Pen NeedleFMI · Special	10/02/2009SE

Questions and answers

When was EasyTouch Lancing Device cleared by the FDA?

EasyTouch Lancing Device (K222617) received a 510(k) decision of Substantially Equivalent on March 21, 2023, 203 days after the submission was received.

What is the product code of K222617?

The FDA product code is QRK – Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature, a Class II (moderate risk) device regulated under 21 CFR 878.4850.