Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
QDJ · Predicate Candidate Screening
3 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Report | 23AndMe, Inc. | 2022-10-26 | 119 | 0 |
| K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Report | 23AndMe, Inc. | 2020-08-17 | 244 | 0 |
| DEN180028 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Report | 23AndMe, Inc. | 2018-10-31 | 148 | 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