FRONT-LINE Field Sterilizer (FL135)

The FRONT-LINE Field Sterilizer (FL135) is a tabletop steam autoclave designed to sterilize heat- and moisture-stable medical, dental, and surgical instruments in healthcare facilities. It uses electric resistive heaters to generate steam and includes multiple pre-programmed sterilization cycles for wrapped instruments, textiles, handpieces, and immediate-use items.

The new device reduces dry times compared to the predicate by adding an external chamber wall heater, replacing the aluminum tray with a stainless steel wire tray for improved heat transfer, implementing a new valve control scheme for better condensate drainage and airflow, and increasing the air pump speed. All other features—chamber size, materials, steam generation method, control system, and safety mechanisms—remain substantially identical to the predicate device.

ANSI/AAMI ST55:2016 (Tabletop Steam Sterilizers); IEC 61010-1 Edition 3.1 2017-01 (Electrical Safety); IEC 61326-1:2020 (EMC Requirements); IEC 61010-2-040:2020 (Sterilizer Safety); ASME Boiler and Pressure Vessel Code Section VIII Division I.

The device is substantially equivalent because it maintains the same indications for use, operating principle (SFPP steam sterilization), chamber design, materials, and safety architecture as the predicate K213457. The modifications to reduce dry times are performance enhancements achieved through incremental engineering changes (surface heater, improved rack, valve control, increased airflow) that do not alter the fundamental sterilization mechanism or safety profile. All performance testing passes the same AAMI ST55:2016 standard that the predicate meets, and the device achieves equivalent or better sterility assurance levels.