FDA applicant
Abbott
FDA records 14 decisions for Abbott (St. Paul, MN) from 2018 to 2026: 13 510(k) clearances and 1 original PMA approval. Most are in product codes DQK (Computer, Diagnostic, Programmable) and MXC (Recorder, Event, Implantable Cardiac, (Without…). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Abbott’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Abbott’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.