Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ssl Americas, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
190 daysmedian FDA review time
488 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM | Ssl Americas, Inc. | 2008-06-19 | 318 | 2 |
| K063385 | DUREX PLAY MASSAGE GEL LUBRICANT | Ssl Americas, Inc. | 2008-03-10 | 488 | 0 |
| K060098 | DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS | Ssl Americas, Inc. | 2006-06-08 | 146 | 0 |
| K042958 | DUREX PLAY TINGLING LUBRICANT | Ssl Americas, Inc. | 2005-04-08 | 163 | 0 |
| K042470 | DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TING | Ssl Americas, Inc. | 2005-04-05 | 204 | 0 |
| K042563 | DUREX PLAY WARMER LUBRICANT | Ssl Americas, Inc. | 2005-02-23 | 155 | 0 |
| K032227 | DUREX FLAVORED LATEX CONDOM | Ssl Americas, Inc. | 2004-03-29 | 252 | 0 |
| K040353 | FLIGHT SOCK | Ssl Americas, Inc. | 2004-03-11 | 28 | 0 |
| K032124 | DUREX PLAY LUBRICANT | Ssl Americas, Inc. | 2004-01-16 | 190 | 0 |
| K020659 | DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | Ssl Americas, Inc. | 2002-03-29 | 28 | 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