De Novo · Granted
GrantedGenetic Variant Detection And Health Risk Assessment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unknown applicant · PTA Genetic Variant Detection And Health Risk Assessment System
Granted as a new device type through De Novo. 3 later devices descend from it.
- Class
- Class II
- Product code
- PTA
- Recalls
- None
3 later devices descend from it, 3 citing it directly.
- This deviceDEN160026 Genetic Variant Detection And Health Risk Assessment System ·
- Descendant · cites it directly · 0 of its ownK221420 AlphaID™ At Home Genetic Health Risk ServiceProgenika Biopharma S.A., A Grifols Company · 2022
- Descendant · cites it directly · 0 of its ownK192073 Helix Genetic Health Risk App for late-onset Alzheimer’s diseaseHelix Opco, LLC · 2020
- Descendant · cites it directly · 0 of its ownK192944 AncestryDNA Factor V Leiden Genetic Health Risk TestAncestry Genomics, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K221420AlphaID™ At Home Genetic Health Risk ServiceProgenika Biopharma S.A., A Grifols Company · 2022 · cites it directly0descendants
- K192073Helix Genetic Health Risk App for late-onset Alzheimer’s diseaseHelix Opco, LLC · 2020 · cites it directly0descendants
- K192944AncestryDNA Factor V Leiden Genetic Health Risk TestAncestry Genomics, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN160026 | Genetic Variant Detection And Health Risk Assessment System | — | ||
| +1 | K221420 | AlphaID™ At Home Genetic Health Risk Service | Progenika Biopharma S.A., A Grifols Company | 2022 | — |
| +1 | K192073 | Helix Genetic Health Risk App for late-onset Alzheimer’s disease | Helix Opco, LLC | 2020 | — |
| +1 | K192944 | AncestryDNA Factor V Leiden Genetic Health Risk Test | Ancestry Genomics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
Sources: FDA De Novo database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PTA? 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 PTA device
- #1 K221420 AlphaID™ At Home Genetic Health Risk Servicescore 4.3 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (3)
3 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, K221420 (Progenika Biopharma S.A., A Grifols Company, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PTA devicesPTA Genetic Variant Detection And Health Risk Assessment System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · PTA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PTA
Too few PTA 510(k)s in any year since 2007 to give a median.
Recalls per year · PTA
No recall names PTA since 2007.
Adverse event reports per year · PTA
1in 2024
MAUDE reports naming product code PTA, 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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/DEN160026 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN160026: Genetic Variant Detection And Health Risk Assessment System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN160026
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026