Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)

The Belmont Rapid Infuser RI-2 is a high-speed infusion pump that warms and delivers blood, blood products, crystalloid and colloid solutions to patients weighing 10 kg or more in hospital and alternative care settings. It infuses fluids at rates from 2.5 to 1000 mL/min for trauma/surgery volume replacement, post-operative rewarming, hypothermia treatment, and urologic irrigation.

The subject device uses a roller-type peristaltic pump with inductively heated stainless steel annular rings for warming. It maintains output temperatures of 37.5°C at high flow (≥60 mL/min) and 39°C at low flow (<60 mL/min), with flow rate accuracy of ±10% from 20-1000 mL/min and ±25% for 2.5-5.0-10 mL/min. It includes redundant ultrasonic air detection, automatic pressure monitoring with 300 mmHg standard limit, and battery backup for 30 minutes at 50 mL/min without heating. The subject device adds higher ingress protection (IPX6 at power cord connection) and updated electrical/EMC standards compared to the predicate.

IEC 60601-1:2005 Ed.3+A1:2012 and IEC 60601-1-2:2020 Ed.4.1 for electrical safety and electromagnetic compatibility; IEC 60529 for ingress protection; ISO 10993-1:2018 for biocompatibility; IEC 60601-1-8 for alarm systems; IEC 62304 for software validation.

The subject device is substantially equivalent to predicate K141654 because both share identical intended use, prescription classification, operating principles, and infusion/warming methods. All critical performance parameters—flow rates, temperature control, pressure monitoring, alarms, operator interface, and safety features—are identical. The differences are minor: updated compliance to current FDA-recognized electrical and EMC standards, improved ingress protection at the power connection, and current biocompatibility testing standards. These differences represent improvements in safety/reliability, not new risks, and do not affect the fundamental intended use or mechanism of action.