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.
Clearance details
- Applicant
- Luminoah
- Product code
- 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.