K241348 is an FDA 510(k) clearance for the SwimCount® Harvester (1 mL). This device is classified as a Labware, Assisted Reproduction (Class II - Special Controls, product code MQK).
Submitted by Motilitycount Aps (Valby, DK). The FDA issued a Cleared decision on January 31, 2025, 263 days after receiving the submission on May 13, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6160.
| 510(k) Number | K241348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2024 |
| Decision Date | January 31, 2025 |
| Days to Decision | 263 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 |