Luminoah FLOW Enteral Nutrition System— 510(k) K253558

Substantially Equivalent

Luminoah

FDA 510(k) clearance K253558 for Luminoah FLOW Enteral Nutrition System, Substantially Equivalent on 2026-04-20. Applicant: Luminoah.

Clearance details

Applicant: Luminoah
Product code: Code LZH
Advisory panel: General Hospital
Date received: 2025-11-17
Decision date: 2026-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottesville, VA, US

Download summary PDF View on FDA.gov ↗

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.