Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
23AndMe, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
237 daysmedian FDA review time
282 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223597 | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk | 23AndMe, Inc. | 2023-08-31 | 272 | 0 |
| K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Report | 23AndMe, Inc. | 2022-10-26 | 119 | 0 |
| K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Canc | 23AndMe, Inc. | 2022-01-06 | 237 | 0 |
| K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Report | 23AndMe, Inc. | 2020-08-17 | 244 | 0 |
| K182784 | MUTYH-Associated Polyposis (MAP) | 23AndMe, Inc. | 2019-01-18 | 109 | 0 |
| DEN180028 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Report | 23AndMe, Inc. | 2018-10-31 | 148 | 0 |
| DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Sele | 23AndMe, Inc. | 2018-03-06 | 182 | 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