Luminoah · Class II · Cleared Apr 20, 2026
| K-number | K253558 |
| Device name | Luminoah FLOW Enteral Nutrition System |
| Applicant | Luminoah |
| Product code | LZH |
| Device class | Class II |
| Decision date | Apr 20, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 880.5725 |
The Luminoah FLOW™ Enteral Nutrition System is an enteral feeding pump and disposable administration sets designed to deliver nutritional formula, fluids, and water to the gastrointestinal system via rotary peristaltic pumping. It is intended for patients ages 2 years and older who cannot obtain sufficient nutrition through eating or swallowing, for use in hospital, acute care, and home health settings by healthcare professionals or laypersons.
The primary difference from the predicate is the sensing methodology: FLOW uses an optical sensor for air detection and motor monitoring (current and pulse width modulation) for occlusion detection, whereas the predicate uses ultrasonic sensors. Both devices employ peristaltic pumping with ENFit connectors, menu-controlled software, similar flow rate ranges (1–600 mL/hr), and rechargeable lithium-ion batteries. FLOW features a simplified two-segment administration set design, includes feed-and-flush capability, and has a 1-year service life versus the predicate's 5 years.
IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, IEC 62304, IEC 62366, IEC 62133 (battery), ISO 10993 (biocompatibility), ISO 80369-3 (ENFit connector), AAMI TIR101:2021 (flow rate accuracy), and FDA guidance documents on infusion pump total product life cycle and human factors engineering.
FLOW is substantially equivalent to the Kangaroo™ Connect predicate because both devices share the same intended use (enteral nutrition delivery), indications for use (patients unable to eat/swallow), target population (ages 2+), treatment method (peristaltic pumping), and core technological function. Design differences in sensor type, administration set architecture, and added flush capability do not introduce safety concerns; motor-based occlusion detection achieves equivalent monitoring of blockage and air-in-line faults, and all performance testing, human factors validation, and regulatory standards compliance demonstrate safe and effective operation.
View the full FDA submission: accessdata.fda.gov