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FDA Predicate Device

Use this FDA Predicate Device template to clearly document the predicate and reference devices your product is being compared to for substantial equivalence in a 510(k) submission. This form is essential for demonstrating how your device aligns with legally marketed devices, and should be completed during the regulatory preparation phase prior to FDA submission. Proper completion helps streamline your FDA review process and ensures all required predicate details are readily available.
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FDA Predicate Device

ID: Lorem ipsum dolor sit amet

1. Purpose

The purpose of this document is to define the predicate devices to be used for substantial equivalence to Consectetur adipiscing elit.

2. Scope

This document covers predicate and potential reference devices related to Consectetur adipiscing elit for submission to the U.S. Food and Drug Administration.

3. Predicate Device Information

Predicate Device Trade Name:
Sed do eiusmod tempor

Predicate Submission Number:
123456

Product Code:
ABC

Product Code Name:
Dolore magna aliqua

4. Reference Device Information

Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.

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