510(k) · Cleared
ClearedEmbryo Predict
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alife Health · PBH Embryo Image Assessment System, Assisted Reproduction
Cleared on May 15, 2026 as substantially equivalent to K142147 (Auxogyn, Inc., 2014) after a 427-day review. Its family tree reaches back 2 generations to 2014.
- Decided
- May 15, 2026
- Review
- 427 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 K243851 Chloe Blastscore 9.9 · 1 generation · 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 |
|---|---|---|---|
| * | K142147 | Eeva SystemSummary page 5…egulation Name: Assisted Reproduction Embryo Image Assessment System Regulation Number: 21 CFR 884.6195 Product Code: PBH Legally Marketed Predicate Device Predicate #: K142147 Predicate Trade Name: Eeva System Product Code(s): PBH The predicate device has not been subject to a design-related recall Dev… | 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 12 years and passes through 2 companies; a new generation was cleared every 11.5 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. 2026, 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?
Embryo Predict is indicated to analyze images of Day 5, 6, and 7 blastocyst-stage embryos (early, expanded, hatching, and hatched) cultured in vitro that have been deemed suitable for transfer by the embryologist.
The device uses patient metadata (patient age, day of embryo culture) and a software algorithm to analyze features of the blastocyst morphology and provides adjunctive information to aid in the assessment of blastocysts when there are multiple embryos deemed suitable for transfer or freezing based on standard morphological assessment.
The device is intended for analysis of blastocyst stage embryos prior to biopsy and cryopreservation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250781 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250781: Embryo Predict.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250781
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026