Luminoah FLOW Enteral Nutrition System— 510(k) K253558
Substantially EquivalentLuminoah
FDA 510(k) clearance K253558 for Luminoah FLOW Enteral Nutrition System, Substantially Equivalent on 2026-04-20. Applicant: Luminoah. Device class: 2.
Summary
Luminoah's Luminoah FLOW Enteral Nutrition System is filed under product code LZH (Pump, Infusion, Enteral).
Class II, 21 CFR 880.5725. General Hospital is both the classification panel and the review panel. It came in as a Traditional 510(k).
Luminoah filed from Charlottesville, Virginia. The record shows 154 calendar days from receipt to decision (November 17, 2025 to April 20, 2026).
Clearance details
- Applicant
- Luminoah
- Product code
- Product code LZH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charlottesville, VA, US
Recent devices under product code LZH
view all- K232205 — Vesco Q Enteral Feeding Pump +4 more
- K221603 — Kangaroo OMNI Enteral Feeding Pump (385400 ) +9 more
- K220230 — AMSure Enteral Feeding Pump
- K200051 — PUGGLE Enteral Feeding Pump and Feeding Set
- K153074 — Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
Adverse events under product code LZH
product code LZH- Death
- 12
- Malfunction
- 4,186
- Total
- 4,198
Source: openFDA MAUDE database, through . 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.