Critikon Company, LLC

Critikon Company, LLC manufactures automated blood pressure monitoring devices, including the Dinamap Vital Signs Monitor series (e.g., Models 9300, 8100T, 1846 SX, Pro Series) for continuous or intermittent cuff-based measurements, as well as central station monitors for multi-patient vital sign tracking. The company also produces infusion pumps like the RateMinder V for controlled intravenous fluid delivery, IV catheter placement units, and disposable IV sets. Additional offerings include electrode/cathéter systems for monitoring and infusion applications, along with modular components like the Sim Module for simulation training.

The company’s devices are classified under FDA categories Class I (low-risk, e.g., IV sets), Class II (moderate-risk, e.g., infusion pumps and vital sign monitors), and Class III (high-risk, e.g., central station monitors requiring premarket approval). Products are listed in the FDA’s 510(k) registry, demonstrating compliance with U.S. regulatory requirements. The manufacturer is based in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.