Sterile Lancets for Single Use
by Ningbo Caremed Medical Products Co., Ltd.
510(k) K242622
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) | NumberK242622 | Date28 Oct 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- Withdrawn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
- QRK
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4850
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
This device is a Single Use Only Blood Lancet Without an Integral Sharps Injury Prevention Feature, classified as a Class 2 medical device under FDA regulation 878.4850. Designed for capillary blood sampling, these sterile lancets are intended for one-time use to puncture the skin and collect small blood samples, commonly used in point-of-care testing, diabetes management, and general laboratory procedures.
The lancets are supplied sterile, intended for single-use only, and fall under the QRK product code for general and plastic surgery applications. They are regulated under both FDA 510(k) clearance (K242622) and the EU Medical Device Regulation (MDR). Multiple FEI numbers (e.g., 3011420269, 1000525253) correspond to different model variants, all adhering to the same regulatory standards. No MRI safety or reusable specifications are indicated.
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Questions
AI-generated answers, 20 Sep 2026
Are these lancets reusable, or are they strictly for single-use only?
These lancets are explicitly designed for single-use only, as stated in the device description. They are not intended for reuse, which helps ensure sterility and safety for capillary blood sampling in point-of-care testing, diabetes management, or laboratory procedures.
What types of regulatory approvals do these lancets hold, and where are they applicable?
The lancets hold FDA 510(k) clearance (K242622) under the classification of a Class 2 medical device (878.4850) and comply with the EU Medical Device Regulation (MDR). These approvals confirm their safety and performance for capillary blood sampling in both the U.S. and European markets.
How are these lancets packaged, and are they sterile upon delivery?
The lancets are supplied sterile, as indicated in the description, meaning they are packaged in a way that maintains sterility until first use. This ensures they are ready for immediate use in clinical settings without additional sterilization steps.
Are there multiple sizes or models available, and how can I identify them?
Yes, multiple model variants exist, each associated with a unique FEI number (e.g., 3011420269, 1000525253). These numbers correspond to different lancet designs or gauges, though the exact specifications (e.g., blade length or depth) are not detailed in the provided data. Check the packaging or documentation for the specific FEI number to confirm the variant.
Can these lancets be used in an MRI environment, or are there any safety concerns?
The device data does not mention MRI safety, meaning there is no explicit confirmation that these lancets are MRI-compatible or safe for use in an MRI environment. Clinicians should verify compatibility with their specific MRI system before use to avoid potential risks.