510(k) · Cleared
ClearedChloe Blast
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fairtility, Ltd. · PBH Embryo Image Assessment System, Assisted Reproduction
Cleared on Aug 15, 2025 as substantially equivalent to DEN120015 (Auxogyn, Inc., 2014) after a 242-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Aug 15, 2025
- Review
- 242 days
- Class
- Class II
- Product code
- PBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN120015 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backDEN120015 EEVA 2.0Auxogyn, Inc. · 2014
- This deviceK243851 Chloe BlastFairtility, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN120015 | EEVA 2.0 | Auxogyn, Inc. | 2014 | — |
| 0 (this device) | K243851 | Chloe Blast | Fairtility, Ltd. | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PBH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PBH device
- #1 K250781 Embryo Predictscore 11.6 · 2 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN120015 | EEVA 2.0Summary page 5…Product Code: PBH (Embryo Image Assessment System, Assisted Reproduction) 4. Predicate Device EEVA 2.0, DEN120015, Auxogyn Inc. The predicate device has not been subject to a design-related recall. 5. Device Description CHLOE BLAST is… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN120015.
How does its category compare?
All PBH devicesPBH Embryo Image Assessment System, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · PBH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBH
Too few PBH 510(k)s in any year since 2007 to give a median.
Recalls per year · PBH
No recall names PBH since 2007.
Adverse event reports per year · PBH
1in 2019
MAUDE reports naming product code PBH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K243851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243851: Chloe Blast.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243851
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026