510(k) K253558
K253558 is an FDA 510(k) premarket notification submitted by Luminoah for the device "Luminoah FLOW Enteral Nutrition System". The FDA issued a decision of Substantially Equivalent on April 20, 2026. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 20, 2026
- Date Received
- November 17, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Enteral
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type