Steam Sterilizer (2545D)

The 2545D is a tabletop steam sterilizer designed to sterilize medical and surgical instruments and devices in healthcare facilities. It uses pressurized steam generated from demineralized water to achieve sterilization of wrapped and unwrapped solid, hollow, and porous loads, including dental handpieces and textiles.

The 2545D uses software-controlled operation with an LCD display and manual door lock (versus the predicate's motor-driven lock). It has a 22-liter chamber (250mm × 450mm) compared to the predicate's 24-liter chamber. Key cycles include Quick 273 (4 min at 134°C), Universal 273, and Universal 250 (30 min at 121°C). Both devices employ the same sterilization principle with heating elements, vacuum mechanisms for air removal, ASME relief valves, and 304L stainless steel construction.

ANSI/UL 61010-1, IEC 61010-2-040:2020, ANSI/AAMI ST55:2016 (Table-Top Steam Sterilizers), IEC 60601-1-2:2020, and IEC 62304:2006+A1:2015 (software life cycle). Testing included Bowie-Dick air removal verification, air leak measurement, temperature control validation, biological performance with tissue and wrapped instrument process challenge devices, and moisture retention assessment.

The 2545D is substantially equivalent because it performs the same intended sterilization function as the predicate (MOST-T Autoclave, K220102) using identical operational principles and sterilization mechanisms. Both devices achieve equivalent sterilization cycles with similar temperature and time parameters; minor differences (manual vs. motor door lock, 2-liter chamber volume difference, and slightly longer drying times) do not raise safety or effectiveness concerns and both meet the same AAMI ST55:2016 and IEC safety standards. Comprehensive testing demonstrates the device achieves the same sterility assurance levels and performance metrics as the predicate.