De Novo · Granted
GrantedEEVA 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Auxogyn, Inc. · PBH Embryo Image Assessment System, Assisted Reproduction
Granted on Jun 6, 2014 as a new device type through De Novo after a 651-day review. 4 later devices descend from it.
- Decided
- Jun 6, 2014
- Review
- 651 days
- Class
- Class II
- Product code
- PBH
- Recalls
- None
4 later devices descend from it, 2 citing it directly.
- This deviceDEN120015 EEVA 2.0Auxogyn, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK142147 Eeva SystemAuxogyn, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK250781 Embryo PredictAlife Health · 2026
- Descendant · cites it directly · 0 of its ownK243851 Chloe BlastFairtility, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK182798 KIDScore D3Vitrolife A/S · 2019
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN120015 | EEVA 2.0 | Auxogyn, Inc. | 2014 | — |
| +1 | K142147 | Eeva System | Auxogyn, Inc. | 2014 | — |
| +2 | K250781 | Embryo Predict | Alife Health | 2026 | — |
| +1 | K243851 | Chloe Blast | Fairtility, Ltd. | 2025 | — |
| +2 | K182798 | KIDScore D3 | Vitrolife A/S | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K142147 (Auxogyn, Inc., 2014) has gone furthest, with 2 descendants of its own.
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. 2014, 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?
The Eeva® System is indicated to provide adjunctive information on events occurring during the first two days of 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 on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN120015 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN120015: EEVA 2.0.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN120015
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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