K243851 is an FDA 510(k) clearance for the CHLOE BLAST. This device is classified as a Embryo Image Assessment System, Assisted Reproduction (Class II — Special Controls, product code PBH).
Submitted by Fairtility , Ltd. (Tel-Aviv, IL). The FDA issued a Cleared decision on August 15, 2025, 242 days after receiving the submission on December 16, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6195. The Device Will Obtain And Analyze Light Microscopy Images Of Developing Embryos. This Device Provides Information To Aid In The Selection Of Embryo(s) For Transfer When There Are Multiple Embryos Deemed Suitable For Transfer Or Freezing ..
| 510(k) Number | K243851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2024 |
| Decision Date | August 15, 2025 |
| Days to Decision | 242 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PBH — Embryo Image Assessment System, Assisted Reproduction |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.6195 |
| Definition | The Device Will Obtain And Analyze Light Microscopy Images Of Developing Embryos. This Device Provides Information To Aid In The Selection Of Embryo(s) For Transfer When There Are Multiple Embryos Deemed Suitable For Transfer Or Freezing . |