# K243851: Chloe Blast

- Pathway: 510(k) (Traditional)
- Applicant: Fairtility, Ltd.
- Decided: Aug 15, 2025 after 242 days
- Product code: PBH (Embryo Image Assessment System, Assisted Reproduction)
- Device class: 2
- Regulation: 21 CFR 884.6195
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN120015 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN120015: EEVA 2.0, Auxogyn, Inc. (2014) Summary page 5.

## Indications for use
CHLOE BLAST is indicated to provide adjunctive information on events occurring during embryo development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3, when, following morphological assessment, there are multiple embryos deemed suitable for transfer or freezing. CHLOE BLAST is to be used only for the analysis of images captured by the EmbryoScope version D incubator system.

Source page: https://510kreport.com/device/K243851
Methodology: https://510kreport.com/methodology