Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jomed AG — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030053 | JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX | Jomed AG | 2003-03-31 | 98 | 0 |
| K020854 | MODIFICATION TO FOX PTA CATHETER | Jomed AG | 2002-04-11 | 27 | 0 |
| K010838 | FOX PTA CATHETER, 3.0, 4.0, 5.0, 6.0, 7.0, AND 8.0 X 40 MM, | Jomed AG | 2001-06-21 | 93 | 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