London Intl., LLC: FDA clearances and approvals
London Intl., LLC has 6 FDA 510(k) clearances (first 1998, latest 1998), across 2 product codes in 2 review panels. Median 510(k) review time: 94 days.
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 | 5 | 5 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
Review panels
Most recent London Intl., LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983380 | DUREX LUBRAGEL LATEX CONDOM | HIS | 1998-11-16 | 52 |
| K982924 | DUREX SENSIDOM LATEX CONDOM | HIS | 1998-11-16 | 88 |
| K980174 | DUREX COLORS AND SCENTS | HIS | 1998-08-13 | 205 |
| K980785 | STERILE, POWDERFREE LATEX EXAMINATION GLOVE | LYY | 1998-06-10 | 100 |
| K980319 | DUREX ULTRA COMFORT | HIS | 1998-05-20 | 113 |
| K980204 | DUREX LATEX CONDOMS | HIS | 1998-04-17 | 87 |
Recalls
openFDA lists no recalls under a recalling firm named London Intl., LLC.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does London Intl., LLC have?
London Intl., LLC has 6 FDA 510(k) clearances (first 1998, latest 1998), across 2 product codes in 2 review panels.
How long does FDA take to clear London Intl., LLC's 510(k)s?
The median time from FDA receipt to decision across London Intl., LLC's cleared 510(k)s is 94 days.
What devices does London Intl., LLC make?
Its most frequent FDA product codes are HIS (Condom, 5); LYY (Latex Patient Examination Glove, 1).
Has London Intl., LLC had device recalls?
openFDA lists no recalls under a recalling firm name matching London Intl., LLC. Related entities may recall under other names.
Next steps
- See all 6 London Intl., LLC clearances with predicates and recalls
- Run predicate analysis for product code HIS, London Intl., LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.