Flashback Technologies, Inc.

Flashback Technologies, Inc. specializes in two primary categories of medical devices: single-use pulse oximeter probes and compensatory reserve tablets. The pulse oximeter probes are designed for monitoring oxygen saturation levels in patients, while the compensatory reserve tablets, such as the CipherOx CRI variants, appear to support respiratory therapy or oxygen delivery in critical care settings. These devices are tailored for clinical use where precise monitoring and controlled oxygen administration are essential.

Flashback Technologies, Inc. is headquartered in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, which govern medical device authorization in the country. The company’s products are listed in the FDA’s regulatory databases, including the 510(k) and UDI (Unique Device Identification) systems, indicating compliance with U.S. requirements for device classification and traceability.

All devices produced by Flashback Technologies, Inc. fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk to patients and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Class II devices are typically authorized through pathways like the 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device.

The devices manufactured by Flashback Technologies, Inc. are included in the FDA’s 510(k) database and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency in device authorization, traceability, and compliance with U.S. regulatory requirements. Listing in these databases confirms that each device has undergone the necessary authorization processes, such as the 510(k) pathway, before entering the market.

The compensatory reserve tablets, such as the CipherOx CRI variants, appear to be designed for critical care or oxygen therapy applications, likely functioning as a controlled-release mechanism to support respiratory support. These devices are classified as Class II, indicating they require regulatory oversight to ensure proper dosing, safety, and efficacy in clinical settings. Their inclusion in the product line reflects a focus on respiratory monitoring and intervention, complementing the company’s pulse oximeter probes for comprehensive patient care.