FDA applicant
Abbott Laboratories
FDA records 920 decisions for Abbott Laboratories (Abbott Park, IL) from 1976 to 2026: 890 510(k) clearances and 30 original PMA approvals. Most are in product codes FRN (Pump, Infusion) and FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 128 for FDA’s reviews in the same codes and years. Its devices cite 223 predicates, 79 of them its own earlier devices. 477 recalls are linked to its devices, 5 Class I.
FDA’s records also spell it “Abbott Laboratories, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Abbott Laboratories’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
10in 2025
Class I Class II/III not classified
Planning a device like Abbott Laboratories’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.