Evenflo Company, Inc.

Evenflo Company, Inc. specializes in infant and lactation care devices. Their portfolio includes infrared forehead thermometers (like the Evenflo® PreciseRead™) for non-contact skin temperature measurement, electric and manual nasal aspirators (such as the Evenflo® QuickAction™) to clear mucus from a baby’s nose, and a variety of breast pumps (e.g., Evenflo Comfort Select, Ameda Platinum, SimplyGo Hands-Free). They also produce teething toys like the Berry Fruity Teether.

Evenflo Company, Inc. is headquartered in the United States, which means its devices are regulated under the FDA’s framework. Since the company manufactures products listed in the FDA’s 510(k) and UDI registries, their devices are subject to U.S. medical device classification rules (Class I or Class II). The U.S. location also influences compliance requirements, such as mandatory UDI labeling and potential 510(k) submissions for non-exempt devices.

Evenflo’s devices appear in the FDA’s 510(k) and UDI (Unique Device Identification) registries—two key databases for tracking authorized medical products in the U.S. The 510(k) registry includes submissions for devices deemed to require premarket notification (typically Class II), while the UDI system ensures traceability via unique identifiers. Listing in these registries confirms compliance with U.S. regulatory requirements, helping healthcare providers verify device authorization and recall history.

Evenflo’s devices fall into Class I or Class II under FDA classification. Class I generally includes low-risk items like some nasal aspirators or teething toys, which may only require general controls (e.g., good manufacturing practices). Class II applies to higher-risk devices like certain breast pumps or advanced thermometers, which require premarket submissions (e.g., 510(k)) to demonstrate safety and effectiveness. Classification determines the regulatory scrutiny and labeling requirements for each product.