Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Southwest Technologies, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
517 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102478 | OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING | Southwest Technologies, Inc. | 2010-11-03 | 65 | 0 |
| K083334 | ELASTO-GEL MANUKA HONEY WOUND DRESSING | Southwest Technologies, Inc. | 2009-07-30 | 260 | 0 |
| K030774 | STIMULEN COLLAGEN | Southwest Technologies, Inc. | 2004-08-09 | 517 | 0 |
| K872488 | ELASTO-GEL CAST & SPLINT PADS | Southwest Technologies, Inc. | 1987-09-21 | 90 | 0 |
| K872165 | ELASTO-GEL OCCLUSIVE DRESSING | Southwest Technologies, Inc. | 1987-06-26 | 21 | 2 |
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