Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Karex Industries Sdn. Bhd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
219 daysmedian FDA review time
263 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223519 | Carex Hybrid Personal Lubricant | Karex Industries Sdn. Bhd. | 2023-08-11 | 261 | 0 |
| K150743 | Water Based Personal Lubricant with Flavours | Karex Industries Sdn. Bhd. | 2015-11-12 | 234 | 0 |
| K141059 | NATURAL RUBBER LATEX MALE CONDOMS | Karex Industries Sdn. Bhd. | 2014-08-01 | 99 | 0 |
| K132597 | BLACK COLOURED CONDOM | Karex Industries Sdn. Bhd. | 2013-11-25 | 98 | 0 |
| K113056 | ORANGE COLORED CONDOMS ORANGE SCENT | Karex Industries Sdn. Bhd. | 2012-07-03 | 263 | 0 |
| K113061 | LARGE/EXTRA LAGRE CONDOM | Karex Industries Sdn. Bhd. | 2011-12-07 | 54 | 0 |
| K081886 | KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERM | Karex Industries Sdn. Bhd. | 2009-02-06 | 219 | 0 |
| K070830 | MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORIN | Karex Industries Sdn. Bhd. | 2007-05-08 | 43 | 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