K223900 is an FDA 510(k) clearance for the babyLance Safety Heelstick (BLM, BLN, BLP), a Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (Class II — Special Controls, product code FMK), submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on February 24, 2023, 58 days after receiving the submission on December 28, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4850.
| 510(k) Number | K223900 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 28, 2022 |
| Decision Date | February 24, 2023 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FMK — Single Use Only Blood Lancet With 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, Non-reusable Base (including An Integral Sharps Injury Prevention Feature) That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. The Integral Sharps Injury Prevention Feature Allows The Device To Be Used Once And Then Renders It Inoperable And Incapable Of Further Use. |