Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
London Intl., LLC · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
205 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983380 | DUREX LUBRAGEL LATEX CONDOM | London Intl., LLC | 1998-11-16 | 52 | 0 |
| K982924 | DUREX SENSIDOM LATEX CONDOM | London Intl., LLC | 1998-11-16 | 88 | 0 |
| K980174 | DUREX COLORS AND SCENTS | London Intl., LLC | 1998-08-13 | 205 | 0 |
| K980785 | STERILE, POWDERFREE LATEX EXAMINATION GLOVE | London Intl., LLC | 1998-06-10 | 100 | 0 |
| K980319 | DUREX ULTRA COMFORT | London Intl., LLC | 1998-05-20 | 113 | 0 |
| K980204 | DUREX LATEX CONDOMS | London Intl., LLC | 1998-04-17 | 87 | 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