Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sulzer Intratherapeutics, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
88 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023243 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH ST | Sulzer Intratherapeutics, Inc. | 2002-12-13 | 74 | 1 |
| K021729 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH ST | Sulzer Intratherapeutics, Inc. | 2002-06-21 | 28 | 0 |
| K021563 | INTRACOIL SELF-EXPANDING PERIPHERAL STENT | Sulzer Intratherapeutics, Inc. | 2002-05-31 | 18 | 0 |
| K020528 | INTRASTENT LD (LARGE DIAMETER) STENT | Sulzer Intratherapeutics, Inc. | 2002-04-16 | 56 | 0 |
| K014136 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH ST | Sulzer Intratherapeutics, Inc. | 2002-01-17 | 31 | 0 |
| K011806 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY | Sulzer Intratherapeutics, Inc. | 2001-09-07 | 88 | 1 |
| K012347 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY | Sulzer Intratherapeutics, Inc. | 2001-08-23 | 30 | 0 |
| K012066 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY | Sulzer Intratherapeutics, Inc. | 2001-08-01 | 30 | 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