FDA applicant
Abbott Diabetes Care, Inc.
FDA records 42 decisions for Abbott Diabetes Care, Inc. (Alameda, CA) from 2000 to 2026: 39 510(k) clearances, 1 De Novo grant and 2 original PMA approvals. Most are in product codes NBW (System, Test, Blood Glucose, Over The Counter) and QLG (Integrated Continuous Glucose Monitoring…). Since 2016 its 510(k)s took a median of 161 days from receipt to decision, against 239 for FDA’s reviews in the same codes and years. Its devices cite 67 predicates, 48 of them its own earlier devices. 27 recalls are linked to its devices, 12 Class I.
FDA’s records also spell it “Abbott Diabetes Care”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Abbott Diabetes Care, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
4in 2025
Class I Class II/III not classified
Planning a device like Abbott 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 “Abbott”
FDA records each applicant name separately; these may or may not be the same firm.