FDA applicant

Karex Industries Sdn. Bhd.

Pontian Kecil, Jalan Johor, MY8 decisions2007–20230 recalls

FDA records 8 decisions for Karex Industries Sdn. Bhd. (Pontian Kecil, Jalan Johor, MY) from 2007 to 2023: 8 510(k) clearances. Most are in product codes HIS (Condom) and NUC (Lubricant, Personal). Its devices cite 6 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Karex Industries Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Karex Industries Sdn. Bhd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Karex Industries Sdn. Bhd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Karex Industries Sdn. Bhd.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?