FDA applicant
Baxterhealthcare, Inc.
FDA records 1 decision for Baxterhealthcare, Inc. (Deerfield Lake, IL) in 2007: 1 510(k) clearance. All are in product code FRN (Pump, Infusion). 19 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Baxterhealthcare, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2007
2007high 1 (2007) · low 0 (2008)2026
2026 so far, outlined.
Recalls per year
6in 2011
2007high 6 (2010) · low 0 (2008)2026
Class I Class II/III not classified
Planning a device like Baxterhealthcare, 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) Report