FDA applicant
Change Healthcare Israel, Ltd.
FDA records 3 decisions for Change Healthcare Israel, Ltd. (Holon, IL) from 2018 to 2023: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and MWI (Monitor, Physiological, Patient (Without…). Since 2016 its 510(k)s took a median of 68 days from receipt to decision, against 116 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Change Healthcare Israel, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Change Healthcare Israel, Ltd.’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 “Change”
FDA records each applicant name separately; these may or may not be the same firm.