Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Swiss American Products, Inc. · 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) |
|---|---|---|---|---|---|
| K103713 | ELTA WOUND CLEANSER | Swiss American Products, Inc. | 2011-06-16 | 177 | 0 |
| K073610 | ELTA ADVANCED WOUND WASH | Swiss American Products, Inc. | 2008-04-23 | 124 | 0 |
| K071703 | ELTA SILVER ANTIMICROBIAL WOUND GEL DRESSING, WOUND AND BURN | Swiss American Products, Inc. | 2007-08-22 | 62 | 0 |
| K932291 | EUTRA GEL FOR WOUND DRESSING | Swiss American Products, Inc. | 1994-07-18 | 434 | 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