FDA applicant

Richter Rubber Technology Sbn Bhd

Durham, NC1 decision2008–20080 recalls

FDA records 1 decision for Richter Rubber Technology Sbn Bhd (Durham, NC) in 2008: 1 510(k) clearance. All are in product code HIS (Condom). Its devices cite 1 predicate, 0 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 Richter Rubber Technology Sbn Bhd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Richter Rubber Technology Sbn Bhd by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Richter Rubber Technology Sbn 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 & Rothe AG 1 Richter Rubber Technology Sdn. Bhd. 1

Richter Rubber Technology Sbn Bhd

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Richter”