MedtFine Safety Lancet
by Ningbo Caremed Medical Products Co., Ltd.
510(k) K241848
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK241848 | Date20 Aug 2024 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- FMK
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4850
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The MedtFine Safety Lancet is a safety lancet (device type: FMK) designed for capillary blood sampling. It features a protective guard to prevent needle-stick injuries, ensuring safe and controlled blood collection from the fingertip or other small blood vessels. The device is intended for single-use applications in clinical and home settings where minimal blood volume is required for diagnostic testing.
This lancet is supplied as a single-use, sterile disposable device and is classified under the FDA’s General & Plastic Surgery category (product code FMK). It is intended for use in environments where infection control is critical, such as hospitals, laboratories, or patient homes. The device adheres to FDA 510(k) clearance (K241848) and MDR compliance, ensuring regulatory alignment for medical use. No MRI safety or reusable specifications are indicated.
Other devices from Ningbo Caremed Medical Products Co., Ltd.
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Questions
AI-generated answers, 18 Sep 2026
What is the MedtFine Safety Lancet designed for, and where can it be used?
The MedtFine Safety Lancet is specifically designed for capillary blood sampling, such as drawing blood from the fingertip or small blood vessels. It is intended for single-use applications in both clinical settings like hospitals and laboratories, as well as home environments where minimal blood volume is required for diagnostic testing. Its protective guard ensures safe and controlled blood collection while minimizing the risk of needle-stick injuries.
Is the MedtFine Safety Lancet reusable, and if not, how should it be disposed of?
The MedtFine Safety Lancet is explicitly designed for single-use only, meaning it should not be reused after one puncture. Since it is a disposable device, proper disposal should follow local medical waste guidelines for sharps to ensure safety and compliance with infection control protocols.
How is the MedtFine Safety Lancet supplied, and is it sterile?
The MedtFine Safety Lancet is supplied as a single-use, sterile disposable device, packaged to maintain sterility until first use. This ensures safe and hygienic blood collection in environments where infection control is critical, such as clinical or home settings.
What regulatory approvals does the MedtFine Safety Lancet have, and how does this affect its use?
The MedtFine Safety Lancet holds FDA 510(k) clearance (K241848) under the General & Plastic Surgery category (product code FMK) and complies with the Medical Device Regulation (MDR). These approvals confirm its regulatory alignment for safe use in medical settings, ensuring it meets established standards for design, manufacturing, and performance.
Are there different sizes or models available for the MedtFine Safety Lancet?
The provided specifications do not detail specific sizes or models of the MedtFine Safety Lancet. For precise sizing options—such as blade depth or gauge—you would need to consult the manufacturer’s product catalog or technical documentation, as these details are not included in the regulatory submission data.