Fisher & Paykel Electronics , Ltd.

Fisher & Paykel Electronics specializes in neonatal and respiratory care devices. Their product line includes infant resuscitators like the RESUBMITTED RD1000 NEOPUFF, temperature monitors such as the MODEL TM101, heated respiratory humidifiers (e.g., HC100, HC200, HC500), wall-mounted infant warmers (e.g., IW980, IW990), CPAP humidifiers, dual servo-controlled respiratory humidification accessories (e.g., MR700/MR720/MR730), and peripheral nerve stimulators like the MODEL NS242. These devices are designed to support critical care in neonatal and respiratory applications.

Fisher & Paykel Electronics is headquartered in the United States. The company’s U.S. presence allows it to develop and distribute its medical devices globally, including those listed in regulatory registries like the FDA’s 510(k) database.

Fisher & Paykel Electronics’ devices are listed in the FDA’s 510(k) registry. This registry includes products that have undergone the 510(k) clearance process, demonstrating that the manufacturer has shown their devices are substantially equivalent to legally marketed predicates. The inclusion in this registry reflects compliance with FDA requirements for Class II devices.

Fisher & Paykel Electronics’ devices are classified as Class II under FDA regulations. Class II devices require special controls to ensure their safety and effectiveness, which may include performance standards, post-market surveillance, or other regulatory measures. The 510(k) clearance process is commonly used for these devices to demonstrate equivalence to existing, legally marketed products.

The 510(k) clearance process is a key regulatory pathway for Fisher & Paykel Electronics’ Class II devices. It involves submitting evidence to the FDA that the device is substantially equivalent to a legally marketed predicate device—either in terms of technology or intended use. This clearance ensures that the device meets applicable safety and effectiveness requirements before being listed in the FDA’s 510(k) registry, supporting its commercial distribution in the U.S. market.