The legally marketed device (s) to which equivalence is drawn is known as the predicate device (s). A claim of substantial equivalence does not mean the device (s) must be identical.

The criteria for determining a substantial equivalence between a predicate device and proposed device are: • The predicate device has the same intended use as the proposed subject device. • The …

A premarket notification, also known as a 510(k), is a premarket submission to the FDA by a device sponsor (“sponsor”) to demonstrate that the device they intend to market in the U.S. is as safe and …

Feb 23, 2026 · What is a predicate device? A predicate device is a legally marketed medical device used as the reference in a 510 (k) submission to demonstrate that a new device is substantially …

May 28, 1976 · A predicate device is a medical device that may be legally marketed in the U.S. and used as a point of comparison for new medical devices seeking approval through the FDA's 510 (k) …

A predicate device (PD) is a medical device that may be legally marketed in the U.S, and used as a point of comparison for new medical devices seeking approval through FDA’s 510 (k) premarket …

May 20, 2025 · A predicate device is a legally marketed medical device that the FDA has already cleared for commercial distribution in the United States through the 510 (k) process.

Nov 26, 2024 · A predicate device is a legally marketed medical device that the FDA has already cleared, which serves as a benchmark to demonstrate that a new device is safe and effective.

Dec 14, 2023 · Information on how to prepare a traditional 510 (k), including how to find a predicate device, related guidance documents, content and format, where to submit, and additional resources.

4 days ago · The FDA should improve device safety by increasing the amount and availability of information about previously marketed devices, known as predicates.