Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wallaby Medical · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
181 daysmedian FDA review time
330 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240917 | Esperance 3+ Aspiration Catheter System | Wallaby Medical | 2024-10-01 | 181 | 0 |
| K231056 | Esperance Distal Access Catheter | Wallaby Medical | 2024-03-08 | 330 | 0 |
| K232437 | Paragon 8F Balloon Guide Catheter | Wallaby Medical | 2023-10-13 | 60 | 0 |
| K223139 | Wallaby 017 Micro Catheter | Wallaby Medical | 2023-04-25 | 203 | 0 |
| K211697 | Esperance Aspiration Catheter System | Wallaby Medical | 2021-11-16 | 166 | 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