Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cenogenics Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
192 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042641 | CHEMVIEW-10 | Cenogenics Corp. | 2005-01-07 | 102 | 0 |
| K030533 | ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOIC | Cenogenics Corp. | 2003-04-17 | 62 | 0 |
| K992397 | ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE | Cenogenics Corp. | 1999-08-26 | 38 | 0 |
| K894793 | MONODEX | Cenogenics Corp. | 1989-08-21 | 24 | 0 |
| K843680 | URI-VAL | Cenogenics Corp. | 1985-03-29 | 192 | 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