23AndMe, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “23AndMe, Inc.” (first 2019, latest 2023), plus 4 De Novo decisions, across 4 product codes in 3 review panels. Median 510(k) review time under this name: 237 days. Since 2017 the median was 237 days, against 237 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 109 |
| 2020 | 1 | 244 |
| 2021 | 0 | — |
| 2022 | 2 | 178 |
| 2023 | 1 | 272 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name 23AndMe, Inc. took a median 237 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 237 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QAZ | Cancer Predisposition Risk Assessment System | 4 | 3 |
| QDJ | Direct-To-Consumer Access Pharmacogenetic Assessment System | 3 | 2 |
| PKB | Autosomal Recessive Carrier Screening Gene Mutation Detection System | 1 | 0 |
| PTA | Genetic Variant Detection And Health Risk Assessment System | 1 | 0 |
Review panels
- Pathology (5)
- Clinical Chemistry (3)
- Immunology (1)
Most recent 23AndMe, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223597 | 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | QAZ | 2023-08-31 | 272 |
| K221885 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | QDJ | 2022-10-26 | 119 |
| K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | QAZ | 2022-01-06 | 237 |
| K193492 | 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports | QDJ | 2020-08-17 | 244 |
| K182784 | MUTYH-Associated Polyposis (MAP) | QAZ | 2019-01-18 | 109 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN180028 | De Novo | Direct-To-Consumer Access Pharmacogenetic Assessment System | 2018-10-31 |
| DEN170046 | De Novo | Cancer Predisposition Risk Assessment System | 2018-03-06 |
| DEN160026 | De Novo | Genetic Variant Detection And Health Risk Assessment System | 2017-04-06 |
| DEN140044 | De Novo | Autosomal Recessive Carrier Screening Gene Mutation Detection System | 2015-02-19 |
Recalls
openFDA lists no recalls under a recalling firm named 23AndMe, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under 23AndMe, Inc.?
FDA lists 5 510(k) clearances under the applicant name “23AndMe, Inc.” (first 2019, latest 2023), plus 4 De Novo decisions, across 4 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by 23AndMe, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name 23AndMe, Inc. is 237 days. Since 2017: 237 days, versus 237 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under 23AndMe, Inc.?
The most frequent FDA product codes under this applicant name are QAZ (Cancer Predisposition Risk Assessment System, 4); QDJ (Direct-To-Consumer Access Pharmacogenetic Assessment System, 3); PKB (Autosomal Recessive Carrier Screening Gene Mutation Detection System, 1).
Next steps
- See all 5 23AndMe, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QAZ, 23AndMe, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.