Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Micrus Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
189 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033813 | MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE | Micrus Corp. | 2004-02-04 | 57 | 0 |
| K032872 | MICRUS MICROCOIL SYSTEM | Micrus Corp. | 2003-11-28 | 74 | 0 |
| K032624 | MICRUS MICROCATHETER | Micrus Corp. | 2003-09-10 | 15 | 0 |
| K031578 | MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR | Micrus Corp. | 2003-08-01 | 73 | 0 |
| K022420 | MICRUS STRETCH-RESISTANT MICROCOIL SYSTEM, MSR01 | Micrus Corp. | 2002-10-22 | 90 | 0 |
| K002056 | MICRUS MICROCOIL DELIVERY SYSTEM, MDS03 | Micrus Corp. | 2001-01-11 | 189 | 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