Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Genepoc, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
92 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K190275 | GenePOC Carba | Genepoc, Inc. | 2019-05-10 | 91 | 0 |
| K183366 | GenePOC Strep A | Genepoc, Inc. | 2019-03-06 | 92 | 0 |
| K172569 | GenePOC CDiff | Genepoc, Inc. | 2017-11-22 | 89 | 1 |
| K170557 | GenePOC GBS LB | Genepoc, Inc. | 2017-05-25 | 90 | 0 |
| K170558 | revogene | Genepoc, Inc. | 2017-05-25 | 90 | 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