ENTERALITE— 510(k) K954735

Name: FDA 510(k) clearance K954735
Creator: U.S. Food and Drug Administration
Published: 1996-04-15

Substantially Equivalent - Subject to Tracking Reg.

Zevex Intl., Inc.

FDA 510(k) clearance K954735 for ENTERALITE, Substantially Equivalent - Subject to Tracking Reg. on 1996-04-15. Applicant: Zevex Intl., Inc.. Device class: 2.

Clearance details

Applicant: Zevex Intl., Inc.
Product code: Code LZH
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1995-10-16
Decision date: 1996-04-15
Decision: Substantially Equivalent - Subject to Tracking Reg.
Clearance type: Traditional
Location: West Jordan, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LZH

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K253558 — Luminoah FLOW Enteral Nutrition System2026-04-20
K232205 — Vesco Q Enteral Feeding Pump +4 more2023-10-23
K221603 — Kangaroo OMNI Enteral Feeding Pump (385400 ) +9 more2022-12-20
K220230 — AMSure Enteral Feeding Pump2022-11-10
K200051 — PUGGLE Enteral Feeding Pump and Feeding Set2020-09-25

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K031199 — ENTERALITE INFINITY ENTERAL FEEDING PUMP2003-07-09

Adverse events under product code LZH

product code LZH

Death: 12
Malfunction: 4,186
Total: 4,198

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.