K241626 is an FDA 510(k) clearance for the SperSort™ Sperm Sorting Chip (IPG02). This device is classified as 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 FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K241626 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |