Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Perfuze, Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
267 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253901 | Millipede88 Access Catheter | Perfuze, Ltd. | 2026-07-09 | 216 | 0 |
| K253590 | Millipede System | Perfuze, Ltd. | 2026-03-16 | 119 | 0 |
| K252392 | Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set | Perfuze, Ltd. | 2025-08-29 | 29 | 0 |
| K250012 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube S | Perfuze, Ltd. | 2025-02-26 | 55 | 0 |
| K240711 | Zipline Access Catheter | Perfuze, Ltd. | 2024-10-17 | 216 | 0 |
| K242504 | Millipede 088 Access Catheter; Millipede 070 Aspiration Cath | Perfuze, Ltd. | 2024-09-20 | 29 | 0 |
| K233648 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2023-12-14 | 30 | 0 |
| K232524 | Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube S | Perfuze, Ltd. | 2023-10-18 | 61 | 0 |
| K231802 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2023-09-19 | 91 | 0 |
| K214048 | Millipede 088 Access Catheter | Perfuze, Ltd. | 2022-09-20 | 267 | 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