Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sulzermedica — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
295 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K002324 | MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA | Sulzermedica | 2000-08-24 | 24 | 1 |
| K993667 | SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS | Sulzermedica | 2000-01-28 | 88 | 0 |
| K990503 | SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS | Sulzermedica | 1999-12-09 | 295 | 1 |
| K993569 | APR METASUL ACETABULAR INSERT | Sulzermedica | 1999-12-01 | 41 | 0 |
| K992832 | SULZER VASCUTEK EPTFE VASCULAR PROSTHESIS | Sulzermedica | 1999-11-19 | 88 | 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