Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QAZ — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| 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 |
| K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Canc | 23AndMe, Inc. | 2022-01-06 | 237 | 0 |
| K182784 | MUTYH-Associated Polyposis (MAP) | 23AndMe, Inc. | 2019-01-18 | 109 | 0 |
| DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Sele | 23AndMe, Inc. | 2018-03-06 | 182 | 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