Ssl Americas, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under 2 spellings of the applicant name “Ssl Americas, Inc.” (first 2002, latest 2008), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 163 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 7 | 7 |
| NUC | Lubricant, Personal | 5 | 5 |
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | 1 | 1 |
| KMJ | Lubricant, Patient | 1 | 1 |
| MOL | Condom, Synthetic | 1 | 1 |
Review panels
Most recent Ssl Americas, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM | MOL | 2008-06-19 | 318 |
| K072236 | DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT | NUC | 2008-05-07 | 271 |
| K071626 | DUREX PLAY SOFT & SENSUAL LUBRICANT | NUC | 2008-04-01 | 292 |
| K063385 | DUREX PLAY MASSAGE GEL LUBRICANT | NUC | 2008-03-10 | 488 |
| K060098 | DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS | NUC | 2006-06-08 | 146 |
| K052959 | DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS | HIS | 2006-01-27 | 98 |
| K042958 | DUREX PLAY TINGLING LUBRICANT | NUC | 2005-04-08 | 163 |
| K042470 | DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM | HIS | 2005-04-05 | 204 |
| K042563 | DUREX PLAY WARMER LUBRICANT | KMJ | 2005-02-23 | 155 |
| K042957 | DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT | HIS | 2005-02-17 | 113 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2002-11-25.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Ssl Americas, Inc. (10)
- Ssl Americas (5)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ssl Americas, Inc.?
FDA lists 15 510(k) clearances under 2 spellings of the applicant name “Ssl Americas, Inc.” (first 2002, latest 2008), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ssl Americas, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ssl Americas, Inc. is 163 days.
Which FDA product codes appear under Ssl Americas, Inc.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 7); NUC (Lubricant, Personal, 5); DWL (Stocking, Medical Support (To Prevent Pooling Of Blood In Legs), 1).
Next steps
- See all 15 Ssl Americas, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Ssl Americas, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.