510(k) · Cleared
ClearedKIDScore D3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vitrolife A/S · PBH Embryo Image Assessment System, Assisted Reproduction
Cleared on Jul 19, 2019 as substantially equivalent to K142147 (Auxogyn, Inc., 2014) after a 290-day review. Its family tree reaches back 2 generations to 2014.
- Decided
- Jul 19, 2019
- Review
- 290 days
- Class
- Class II
- Product code
- PBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN120015 (2014). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K142147 | Eeva SystemSummary page 4…ssment System Product Code: PBH (Embryo Image Assessment System, Assisted Reproduction) Regulatory Class II 4. Predicate Device Eeva(TM) System, K142147, Auxogyn Inc. The predicate device has not been subject to any design related recalls. 5. Device Description The KIDScore D3 d… | 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K142147.
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. 2019, 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 KIDScore D3 tool provides decision support for prediction of likelihood of embryos developing to the blastocyst stage by scoring them according to their statistical viability.
Adjunctive information provided by KIDScore D3 aids in the selection of embryo(s) for either transfer on Day 3, freezing or continued embryo development when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
The KIDScore D3 tool is only to be used with the EmbryoScope and EmbryoScope+ timelapse incubator systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182798 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182798: KIDScore D3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182798
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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