K221613 is an FDA 510(k) clearance for the Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets. This device is classified as a Multiple Use Blood Lancet For Single Patient Use Only (Class II - Special Controls, product code QRL).
Submitted by Owen Mumford, Ltd. (Woodstock, GB). The FDA issued a Cleared decision on October 3, 2022, 122 days after receiving the submission on June 3, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4850. A Multiple Use Capable Blood Lancet Intended For Use On A Single Patient That Is Comprised Of A Single Use Blade Attached To A Solid, Reusable Base That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes..
| 510(k) Number | K221613 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 2022 |
| Decision Date | October 03, 2022 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QRL - Multiple Use Blood Lancet For Single Patient Use Only |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4850 |
| Definition | A Multiple Use Capable Blood Lancet Intended For Use On A Single Patient That Is Comprised Of A Single Use Blade Attached To A Solid, Reusable Base That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. |