Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OYJ · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
266 daysmedian FDA review time
423 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212745 | ORAcollect®•Dx | DNA Genotek, Inc. | 2022-10-27 | 423 | 0 |
| K192947 | AncestryDNA Saliva Collection Kit | Ancestry Genomics, Inc. | 2020-08-13 | 300 | 0 |
| K192920 | Oragene®•Dx | DNA Genotek, Inc. | 2020-01-14 | 90 | 0 |
| K152464 | ORAcollect.Dx | DNA Genotek, Inc. | 2016-05-26 | 269 | 0 |
| K152556 | Oragene Dx | DNA Genotek, Inc. | 2016-05-26 | 261 | 0 |
| K141410 | ORAGENE DX OGD-500.001 | DNA Genotek, Inc. | 2015-02-19 | 266 | 0 |
| K110701 | ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; | DNA Genotek, Inc. | 2011-12-02 | 263 | 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