FDA applicant
Zevex Intl., Inc.
FDA records 2 decisions for Zevex Intl., Inc. (West Jordan, UT) from 1996 to 2003: 2 510(k) clearances. All are in product code LZH (Pump, Infusion, Enteral). Its devices cite 3 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Zevex Intl., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Zevex Intl., Inc. since 2007.
Recalls per year
2in 2012
Class I Class II/III not classified
Planning a device like Zevex Intl., 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 “Zevex”
FDA records each applicant name separately; these may or may not be the same firm.