Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Porges S.A. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013921 | PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / B | Porges S.A. | 2002-10-17 | 324 | 0 |
| K021856 | PORGES URETERAL CATHETERS, MODELS ACN6XX, ACN5XX, AC5B, AC5C | Porges S.A. | 2002-10-17 | 133 | 0 |
| K013174 | PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL | Porges S.A. | 2002-01-04 | 102 | 0 |
| K013172 | PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL | Porges S.A. | 2001-12-20 | 87 | 1 |
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