FDA Clearance Documents
What is the FDA?
The FDA is a U.S. government agency responsible for helping protect public health by regulating many products, including medical devices. For certain device types, manufacturers must meet regulatory requirements before the device can be legally marketed in the U.S.
What does “FDA cleared” mean?
Many medical devices enter the U.S. market through the FDA’s 510(k) premarket notification pathway. When a device is “FDA cleared,” it means the FDA determined the device is substantially equivalent to a legally marketed predicate device for its intended use.
Important: “Cleared” vs. “Approved”
FDA cleared (510(k)) is different from FDA approved. “Approval” typically refers to a different pathway for certain higher-risk devices. For clarity and accuracy, we describe our products as “FDA cleared” where applicable.
Also note: terms like “FDA certified” can be misleading. We provide the official 510(k) summaries below as supporting documentation.
Download 510(k) Summaries (PDF)
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Documents are provided for reference. Product use should follow the intended use and labeling. If you have trouble downloading, please contact our support team.