K223815 is an FDA 510(k) clearance for the ONE DROP Lancing Device. This device is classified as a Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature (Class II - Special Controls, product code QRK).
Submitted by Stat Medical Devices (North Miami Beach, US). The FDA issued a Cleared decision on February 15, 2023, 57 days after receiving the submission on December 20, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4850. A Disposable Blood Lancet Intended For A Single Use That Is Comprised Of A Single Use Blade Attached To A Solid, Nonreusable Base That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes..
| 510(k) Number | K223815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2022 |
| Decision Date | February 15, 2023 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QRK - Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4850 |
| Definition | A Disposable Blood Lancet Intended For A Single Use That Is Comprised Of A Single Use Blade Attached To A Solid, Nonreusable Base That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. |