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510(k) clearance

The FDA’s process for clearing medical devices, including vacuum erection devices, based on their substantial equivalence to a legally marketed predicate device.

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Jan 14, 2026

How can a patient verify that a specific vacuum erection device is FDA‑cleared (510(k))?

A patient can definitively verify whether a specific vacuum erection device (VED) is FDA‑cleared by locating the device’s 510(k) (K‑number) and confirming that number in the FDA’s official 510(k) data...