Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PTA · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
282 daysmedian FDA review time
509 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241456 | GlutenID Celiac Genetic Health Risk Test | Targeted Genomics, LLC | 2025-01-07 | 230 | 0 |
| K221420 | AlphaID™ At Home Genetic Health Risk Service | Progenika Biopharma S.A., A Grifols Company | 2022-10-27 | 164 | 0 |
| K192073 | Helix Genetic Health Risk App for late-onset Alzheimer’s dis | Helix Opco, LLC | 2020-12-23 | 509 | 0 |
| K192944 | AncestryDNA Factor V Leiden Genetic Health Risk Test | Ancestry Genomics, Inc. | 2020-08-13 | 300 | 0 |
| DEN160026 | 23andMe Personal Genome Service (PGS) Genetic Health Risk Te | 23AndMe, Inc. | 2017-04-06 | 282 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda