FDA applicant
Boehringer Mannheim Corp.
FDA records 341 decisions for Boehringer Mannheim Corp. (Indianapolis, IN) from 1976 to 1999: 340 510(k) clearances and 1 original PMA approval. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and CGA (Glucose Oxidase, Glucose). Its devices cite 89 predicates, 38 of them its own earlier devices. 77 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Boehringer Mannheim Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Boehringer Mannheim Corp. since 2007.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Boehringer Mannheim Corp.’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 “Boehringer”
FDA records each applicant name separately; these may or may not be the same firm.