FDA applicant
Abbott Medical
FDA records 92 decisions for Abbott Medical (St. Paul, MN) from 1982 to 2026: 60 510(k) clearances and 32 original PMA approvals. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 58 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 78 predicates, 30 of them its own earlier devices. 146 recalls are linked to its devices, 35 Class I.
FDA’s records also spell it “Abbott Medical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Abbott Medical’s devices, and how often a recall has named them.
FDA decisions per year
15in 2025
2026 so far, outlined.
Recalls per year
5in 2026
Class I Class II/III not classified
Planning a device like Abbott Medical’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.