Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Q’Apel Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
136 daysmedian FDA review time
344 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254276 | Lynx Aspiration Catheter System | Q’Apel Medical, Inc. | 2026-05-07 | 128 | 0 |
| K240746 | Neurovascular Access System Family | Q'Apel Medical, Inc. | 2024-11-20 | 246 | 0 |
| K222786 | 072 Aspiration System | Q'Apel Medical, Inc. | 2023-08-25 | 344 | 1 |
| K230322 | SelectFlex Neurovascular Access System Family | Q'Apel Medical, Inc. | 2023-06-22 | 136 | 0 |
| K211893 | SelectFlex Neurovascular Access System Family | Q'Apel Medical, Inc. | 2021-08-05 | 45 | 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