Karex Industries Sdn. Bhd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Karex Industries Sdn. Bhd.” (first 2007, latest 2023), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 159 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 | 1 | 263 |
| 2013 | 1 | 98 |
| 2014 | 1 | 99 |
| 2015 | 1 | 234 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 261 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Karex Industries Sdn. Bhd. took a median 261 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HIS | Condom | 6 | 6 |
| NUC | Lubricant, Personal | 2 | 2 |
Review panels
Most recent Karex Industries Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223519 | Carex Hybrid Personal Lubricant | NUC | 2023-08-11 | 261 |
| K150743 | Water Based Personal Lubricant with Flavours | NUC | 2015-11-12 | 234 |
| K141059 | NATURAL RUBBER LATEX MALE CONDOMS | HIS | 2014-08-01 | 99 |
| K132597 | BLACK COLOURED CONDOM | HIS | 2013-11-25 | 98 |
| K113056 | ORANGE COLORED CONDOMS ORANGE SCENT | HIS | 2012-07-03 | 263 |
| K113061 | LARGE/EXTRA LAGRE CONDOM | HIS | 2011-12-07 | 54 |
| K081886 | KAREX INDUSTRIES MALE NATURAL RUBBER LATEX CONDOM, NON-SPERMICIDAL, LUBRICATED AND NON LUBRICATED | HIS | 2009-02-06 | 219 |
| K070830 | MALE NATURAL RUBBER LATEX CONDOM (WITH COLORING AND FLAVORING) | HIS | 2007-05-08 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Karex Industries Sdn. Bhd..
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.
Device clinical trials
An industry sponsor named Karex Industries Sdn. Bhd. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT06079060: Evaluation of Synthetic Nitrile Male Condom Compared to Standard Latex Male Condom (Completed, started 2023-10-06)
- NCT05912283: Evaluation of 2 Synthetic Nitrile Male Condoms Compared to a Standard Latex Male Condom (Completed, started 2023-06-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Karex Industries Sdn. Bhd.?
FDA lists 8 510(k) clearances under the applicant name “Karex Industries Sdn. Bhd.” (first 2007, latest 2023), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Karex Industries Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Karex Industries Sdn. Bhd. is 159 days.
Which FDA product codes appear under Karex Industries Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are HIS (Condom, 6); NUC (Lubricant, Personal, 2).
Next steps
- See all 8 Karex Industries Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code HIS, Karex Industries Sdn. Bhd.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.