Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer

The Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is a fully automatic tabletop autoclave designed for medical, dental, surgical, healthcare, and laboratory settings. It uses saturated steam under pressure with vacuum-assisted cycles to sterilize heat and moisture-stable reusable instruments, textiles, and porous loads in wrapped or unwrapped configurations, with integrated drying capability.

The device features a 25-liter stainless steel chamber (316L), microprocessor control with pre-set Class B and S sterilization cycles, vacuum system for air removal and drying, built-in thermal printer, and onboard water distiller. It differs from the predicate T-Top 11 in outer casing material (carbon steel vs. polycarbonate), chamber steel grade (316L vs. 304L), and door construction (aluminum hard anodized vs. stainless steel), but shares identical sterilization parameters, chamber volume, vacuum principle, and electrical specifications.

Testing per IEC 61010-1, IEC 60601-1-2, AAMI/ANSI ST55, IEC 62304, IEC 62366-1, ISO 17665-1, and IEC TR 60601-4-2. Device performance validated through Bowie & Dick tests, air-leak-rate tests, empty and full chamber thermal tests, and biological indicator testing demonstrating 10⁻⁶ sterility assurance level.

The Life Ultra 25L is substantially equivalent to the predicate T-Top 11 because both devices share identical intended use (medical/surgical sterilization), principle of operation (moist heat steam sterilization under pressure), sterilization parameters (same Class B and S cycles at identical temperatures and times), chamber volume (~25-26 liters), vacuum-assisted air removal and drying functionality, and electrical specifications. Material differences are non-critical to function, and all performance testing successfully met the same FDA-recognized consensus standards.