510(k) Report

FDA applicant

Zevex Intl., Inc.

West Jordan, UT2 decisions1996–20034 recalls

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, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

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

2008: 22012: 2
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Zevex Intl., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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Other applicant names beginning “Zevex”

FDA records each applicant name separately; these may or may not be the same firm.