FDA applicant
Carefusion 2200, Inc.
FDA records 14 decisions for Carefusion 2200, Inc. (Vernon Hills, IL) from 2009 to 2021: 14 510(k) clearances. Most are in product codes KCT (Sterilization Wrap Containers, Trays…) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 137 days from receipt to decision, against 120 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 4 of them its own earlier devices. 6 recalls are linked to its devices, 4 Class I.
FDA’s records also spell it “Carefusion 2200”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Carefusion 2200, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Carefusion 2200, 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) ReportOther applicant names beginning “Carefusion”
FDA records each applicant name separately; these may or may not be the same firm.