FDA applicant

Richter Rubber Technology Sdn. Bhd.

Louisville, KY1 decision2001–20010 recalls

FDA records 1 decision for Richter Rubber Technology Sdn. Bhd. (Louisville, KY) in 2001: 1 510(k) clearance. All are in product code HIS (Condom). 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 Richter Rubber Technology Sdn. Bhd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Richter Rubber Technology Sdn. Bhd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Richter”

FDA records each applicant name separately; these may or may not be the same firm.

Richter Rubber Technology Sbn Bhd 1 Richter & Rothe AG 1

Richter Rubber Technology Sdn. Bhd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Richter”