Disposable Safety Lancet
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K222408 FDA 510(k)
- FDA Product Code
- FMK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4850 FDA 510(k)
- Regulation Number
- 878.4850 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Disposable Safety Lancet is a single-use, sterile medical device designed for safe and controlled blood collection. Classified as a disposable lancet under nomenclature authorities, it is intended for puncturing the skin to obtain capillary blood samples, minimizing the risk of contamination or injury through its disposable, non-reusable design.
This device is supplied in a sterile, single-use packaging for clinical, home, or field use. It complies with FDA 510(k) clearance under the Substantially Equivalent determination (K222408) and EU MDR regulations. The lancet is intended for one-time use only and must be discarded after use to prevent cross-contamination. No MRI safety information is specified, and storage should follow manufacturer guidelines to maintain sterility.
Frequently asked questions
What is the primary purpose of the Disposable Safety Lancet and why is it designed for single-use only?
The Disposable Safety Lancet is designed for safe and controlled blood collection by puncturing the skin to obtain capillary blood samples. It is made for single-use only to minimize the risk of contamination or injury, ensuring patient safety by preventing cross-contamination from reuse.
How is the Disposable Safety Lancet packaged and what precautions should be taken during storage?
The Disposable Safety Lancet comes in sterile, single-use packaging suitable for clinical, home, or field use. To maintain sterility, storage should strictly follow the manufacturer’s guidelines, as no specific storage instructions are provided in the data.
Can this lancet be reused, and if not, what happens if it is reused?
No, the Disposable Safety Lancet is explicitly intended for one-time use only. Reusing it would violate its design purpose and could introduce risks of contamination or injury, as the device is not engineered for repeated use.
What regulatory pathways has the Disposable Safety Lancet followed, and where is it manufactured?
The lancet has undergone FDA 510(k) clearance under the Substantially Equivalent determination (K222408) and complies with EU MDR regulations. It is manufactured by Beijing Ruicheng Medical Supplies Co., Ltd., located at #13 Yanqi Ave., Yanqi Economic Development Zone, Huairou District, Beijing, China.
Are there any special considerations for using this lancet in environments like MRI facilities?
The data does not specify any MRI safety information for the Disposable Safety Lancet, so its use in MRI environments should be approached with caution or avoided unless confirmed safe by the manufacturer or regulatory documentation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Lancet Manufacturer | Ruichengmedical, Beijing Ruicheng Medical Supplies Co.,Ltd., Beijing Ruicheng Medical Supplies Co., Ltd., 2026 Disposable Lancet - Beijing Ruicheng Medical Supplies Co., Ltd ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222408 | Class II | Active |
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Manufacturer
- Manufacturer
- Beijing Ruicheng Medical Supplies Co., Ltd.
Sources (2)
- FDA 510(k) K222408 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026