K221062 is an FDA 510(k) clearance for the RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device. This device is classified as a Multiple Use Blood Lancet For Single Patient Use Only (Class II - Special Controls, product code QRL).
Submitted by Bionime Corporation (Taichung City, TW). The FDA issued a Cleared decision on September 26, 2022, 168 days after receiving the submission on April 11, 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 | K221062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 11, 2022 |
| Decision Date | September 26, 2022 |
| Days to Decision | 168 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. |