Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cerenovus, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
258 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251828 | CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Se | Cerenovus, Inc. | 2025-08-22 | 70 | 0 |
| K241221 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediat | Cerenovus, Inc. | 2024-10-16 | 168 | 0 |
| K241244 | CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediat | Cerenovus, Inc. | 2024-10-16 | 167 | 0 |
| K233982 | CEREGLIDE 92 Catheter System | Cerenovus, Inc. | 2024-05-09 | 143 | 0 |
| K233988 | Cerenovus Large Bore Catheter; Cerenovus Aspiration Tubing S | Cerenovus, Inc. | 2024-01-17 | 30 | 0 |
| K230726 | CEREGLIDE 92 Intermediate Catheter | Cerenovus, Inc. | 2023-11-29 | 258 | 0 |
| K221934 | CEREGLIDE 71 Intermediate Catheter; Cerenovus Aspiration Tub | Cerenovus, Inc. | 2023-03-09 | 251 | 0 |
| K221930 | CEREGLIDE 71 Intermediate Catheter | Cerenovus, Inc. | 2023-03-09 | 251 | 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