Disposable Blood Lancet (Soft Pro, Softsure, Softsure Pro, Softsense)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K244031 FDA 510(k)
- FDA Product Code
- QRK FDA 510(k)
- Models / Variants
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 Blood Lancet (Soft Pro, Softsure, Softsure Pro, Softsense) is a single-use, sterile, plastic surgical instrument designed for percutaneous blood sampling. Classified as a single-use only blood lancet without an integral sharps injury prevention feature, it is intended for controlled skin punctures to obtain capillary blood samples.
These lancets are supplied individually packaged and intended for one-time use only. They comply with FDA 510(k) clearance and EU MDR requirements, falling under device class II. Each variant is identified by distinct model references and is non-reusable, ensuring patient safety and sterility. Storage conditions require protection from contamination and extreme temperatures, adhering to standard medical device handling protocols.
Frequently asked questions
Are these blood lancets reusable, or are they designed for single-use only?
These lancets are explicitly designed for single-use only and must not be reused. The manufacturer emphasizes this in the description to ensure patient safety and sterility, as reuse could compromise sterility and increase infection risks.
How should I store these lancets to maintain their integrity and sterility?
Storage requires protection from contamination and extreme temperatures. The packaging is designed for individual use, so keep them in their original, sealed containers until ready for use. Follow standard medical device handling protocols to preserve sterility and functionality.
What regulatory pathways have these blood lancets gone through, and what does that mean for me?
These lancets have received FDA 510(k) clearance and comply with EU MDR requirements, classified as Class II devices. This means they’ve undergone rigorous review for safety and performance, ensuring they meet regulatory standards for use in percutaneous blood sampling.
Are there different models or variants of these lancets, and how can I identify them?
Yes, there are four distinct variants: Soft Pro, Softsure, Softsure Pro, and Softsense. Each variant is identified by unique model references and is non-reusable, ensuring patient safety. The manufacturer provides these variants to cater to different clinical preferences or procedural needs.
What is the purpose of these lancets, and what type of blood samples can they obtain?
These lancets are designed for percutaneous blood sampling to obtain capillary blood samples through controlled skin punctures. They are not intended for venous or arterial blood draws but are suitable for routine blood glucose monitoring, hematology tests, or other capillary blood tests.
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.
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 | K244031 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterilance Medical (Suzhou) Inc.
- FDA Applicant
- SteriLance Medical (Suzhou), Inc.
Sources (2)
- FDA 510(k) K244031 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026