510(k) · Cleared
ClearedEeva System
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
Cleared on Nov 24, 2014 as substantially equivalent to DEN120015 (Auxogyn, Inc., 2014) and 1 other predicate after a 111-day review. Its family tree reaches back 1 generation to 2014. 2 later devices descend from it.
- Decided
- Nov 24, 2014
- Review
- 111 days
- Class
- Class II
- Product code
- PBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to DEN120015 (2014). 2 later devices descend from it, 2 citing it directly.
Most influential descendants
Showing 2 of 2 · See allView 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) | K142147 | Eeva System | Auxogyn, Inc. | 2014 | — |
| +1 | K250781 | Embryo Predict | Alife Health | 2026 | — |
| +1 | K182798 | KIDScore D3 | Vitrolife A/S | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2026 | 1 | 0 |
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
- #2 Held for the reportin the report
What was it cleared against? (2)
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 2.0 Our reading of the summary gave K120427, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120015, EEVA 2.0 (Auxogyn, Inc.), granted Jun 6, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2014 |
| * | DEN120015 | EEVA 2.0Summary page 4…21 CFR 884.6195 Product Code: PBH Device Class: II Predicate Device: Eeva System, Model EVS2000; K120427, DEN120015 This predicate has not been subject to a design-related recall.… | 2014 |
What descends from it? (2)
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?
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. The device may also be used to collect additional time-lapse images until Day 5 of development for embryos not selected for transfer, to allow monitoring of continued embryo development.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142147 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142147: Eeva System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142147
Report an extraction error
Are you the manufacturer?
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