FDA applicant
Roche Diabetes Care, Inc.
FDA records 13 decisions for Roche Diabetes Care, Inc. (Indianapolis, IN) from 2012 to 2023: 13 510(k) clearances. Most are in product codes FMK (Single Use Only Blood Lancet With An Integral…) and NBW (System, Test, Blood Glucose, Over The Counter). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 7 of them its own earlier devices. 8 recalls are linked to its devices.
FDA’s records also spell it “Roche Diabetes Care GmbH”, “Roche Diabetes Care”, “Roche Diabetes Care AG”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Roche Diabetes Care, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2023
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Roche Diabetes Care, Inc.’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 “Roche”
FDA records each applicant name separately; these may or may not be the same firm.