MedtFine Blood Lancet
by Shanghai Carelife International Trading Co., Ltd.
510(k) K221383
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK221383 | Date21 Sep 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- QRK
- FDA applicant
- Shanghai Carelife International Trading Co. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4850
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The MedtFine Blood Lancet is a single-use, disposable blood lancet without an integral sharps injury prevention feature. It is designed for percutaneous skin puncture to collect capillary blood samples, commonly used in glucose monitoring, hematology, and other diagnostic procedures requiring minimal blood volume. Constructed from plastic, it is engineered for precision and reduced patient discomfort during use.
Supplied as a sterile, single-use device, the MedtFine Blood Lancet adheres to 21 CFR 878.4850 regulations and is classified under FDA Class II with product code QRK. It is intended for clinical settings, including general and plastic surgery, and must be stored as directed by the manufacturer to maintain sterility and functionality prior to use.
MedtFine Blood Lancet
Other devices from Shanghai Carelife International Trading Co., Ltd.
Questions
AI-generated answers, 1 Oct 2026
What is the MedtFine Blood Lancet used for?
The MedtFine Blood Lancet is designed for percutaneous skin puncture to collect small capillary blood samples. It is commonly used in glucose monitoring, hematology testing, and other diagnostic procedures where minimal blood volume is required. Its precision engineering helps reduce patient discomfort during use.
Is the MedtFine Blood Lancet single-use or reusable?
The MedtFine Blood Lancet is explicitly designed for single-use only. It is a disposable device, meaning each unit is intended for one-time use and should not be reused or reprocessed. This ensures sterility and safety for patients.
How is the MedtFine Blood Lancet supplied and stored?
The MedtFine Blood Lancet is supplied as a sterile, single-use device in packaging that maintains its integrity until first use. To preserve sterility and functionality, it must be stored as directed by the manufacturer—typically in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the manufacturer’s instructions for specific storage guidelines.
Does the MedtFine Blood Lancet have a sharps injury prevention feature?
No, the MedtFine Blood Lancet does not include an integral sharps injury prevention feature. It is a standard plastic lancet designed for safe, controlled skin puncture without built-in safety mechanisms like retractable needles. Proper disposal in a sharps container after use is essential to prevent injuries.
What regulatory classification does the MedtFine Blood Lancet hold?
The MedtFine Blood Lancet is classified under FDA Class II with product code QRK, adhering to 21 CFR 878.4850 regulations. It was determined to be substantially equivalent through a traditional 510(k) clearance process, with the decision made by the FDA’s Skin and Soft Tissue Infections (SU) Advisory Committee in 2022. This classification ensures it meets established safety and effectiveness standards for its intended use.