K241626 is an FDA 510(k) clearance for the SperSort? Sperm Sorting Chip (IPG02), a Labware, Assisted Reproduction (Class II — Special Controls, product code MQK), submitted by Ipreg Incorporation (New Taipei City, TW). The FDA issued a Cleared decision on February 20, 2025, 259 days after receiving the submission on June 6, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K241626 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 06, 2024 |
| Decision Date | February 20, 2025 |
| Days to Decision | 259 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MQK — Labware, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6160 |