Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ceevra, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
271 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243933 | Ceevra Reveal 3+ | Ceevra, Inc. | 2025-03-04 | 74 | 0 |
| K233568 | Ceevra Reveal 3+ | Ceevra, Inc. | 2023-12-05 | 29 | 0 |
| K222676 | Ceevra Reveal 3 | Ceevra, Inc. | 2023-04-25 | 231 | 0 |
| K173274 | Ceevra Reveal 2.0 | Ceevra, Inc. | 2018-07-10 | 271 | 0 |
| K171356 | Clarity Reveal | Ceevra, Inc. | 2017-08-03 | 86 | 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