Verifine Safety Lancets
FDA 510(k) K261045 · Promisemed Hangzhou Meditech Co., Ltd.
Submission
- Device name
- Verifine Safety Lancets
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
Hangzhou City, CN - Received
- March 31, 2026
- Decision date
- May 1, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMK – Single Use Only Blood Lancet With 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, 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…
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|---|---|---|
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| K250192 | Verisafe Safety Retractable Insulin SyringesFMF · Traditional | 12/10/2025SE |
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| K251138 | Promisemed Safety Huber NeedlesPTI · Special | 05/13/2025SE |
| K243332 | Promisemed Safety Huber NeedlesPTI · Special | 03/14/2025SE |
| K243806 | Safety Winged Blood Collection SetsFMI · Special | 01/10/2025SE |
| K240675 | Endoscopic Injection NeedlesFBK · Traditional | 10/04/2024SE |
| K242632 | Verifine® Pen NeedlesFMI · Special | 09/26/2024SE |
Questions and answers
When was Verifine Safety Lancets cleared by the FDA?
Verifine Safety Lancets (K261045) received a 510(k) decision of Substantially Equivalent on May 1, 2026, 31 days after the submission was received.
What is the product code of K261045?
The FDA product code is FMK – Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, a Class II (moderate risk) device regulated under 21 CFR 878.4850.