FDA applicant
Baxter Healthcare Corp
FDA records 574 decisions for Baxter Healthcare Corp (Round Lake, IL) from 1977 to 2025: 568 510(k) clearances, 1 De Novo grant and 5 original PMA approvals. Most are in product codes FPA (Set, Administration, Intravascular) and FRN (Pump, Infusion). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 194 for FDA’s reviews in the same codes and years. Its devices cite 214 predicates, 126 of them its own earlier devices. 421 recalls are linked to its devices, 32 Class I.
FDA’s records also spell it “Baxter Healthcare Corporation”, “Baxter Healthcare”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Baxter Healthcare Corp’s devices, and how often a recall has named them.
FDA decisions per year
5in 2025
2026 so far, outlined.
Recalls per year
6in 2026
Class I Class II/III not classified
Planning a device like Baxter Healthcare Corp’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 “Baxter”
FDA records each applicant name separately; these may or may not be the same firm.