Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ssl Americas — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
292 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072236 | DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT | Ssl Americas | 2008-05-07 | 271 | 0 |
| K071626 | DUREX PLAY SOFT & SENSUAL LUBRICANT | Ssl Americas | 2008-04-01 | 292 | 0 |
| K052959 | DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS | Ssl Americas | 2006-01-27 | 98 | 0 |
| K042957 | DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT | Ssl Americas | 2005-02-17 | 113 | 0 |
| K040185 | DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM | Ssl Americas | 2004-04-27 | 91 | 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