Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spirus Medical, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
186 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080050 | SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE | Spirus Medical, Inc. | 2008-05-06 | 119 | 0 |
| K080042 | SPIRUS MEDICAL SURGICAL INSTRUMENT | Spirus Medical, Inc. | 2008-04-03 | 86 | 0 |
| K062805 | MODIFICATION TO ENDO-EASE | Spirus Medical, Inc. | 2006-10-13 | 24 | 0 |
| K060235 | ENDO-EASE ENDOSCOPIC OVERTUBE | Spirus Medical, Inc. | 2006-08-04 | 186 | 0 |
| K052084 | ENDO-EASE ENDOSCOPIC OVERTUBE | Spirus Medical, Inc. | 2005-09-14 | 43 | 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