FDA applicant
Rudolf Riester GmbH & Co. KG
FDA records 33 decisions for Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE) from 1993 to 2019: 33 510(k) clearances. Most are in product codes ERA (Otoscope) and DXQ (Blood Pressure Cuff). Since 2016 its 510(k)s took a median of 163 days from receipt to decision, against 174 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Rudolf Riester GmbH”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Rudolf Riester GmbH & Co. KG’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Rudolf Riester GmbH & Co. KG’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) ReportOther applicant names beginning “Rudolf”
FDA records each applicant name separately; these may or may not be the same firm.