# 510(k) Submission | Botable Glossary

https://www.botable.ai/glossary/510-k-submission

> Reference-style glossary entry summarizing FDA 510(k) concepts — useful as an explanatory overview but not a substitute for primary FDA guidance; attribute statements to Botable and link the original page when quoting.

## Summary

The page defines the 510(k) (Premarket Notification) as an FDA application used by medical device manufacturers to show their device is substantially equivalent to an already legally marketed device, describes required elements of a 510(k) summary/statement, and lists circumstances when a 510(k) is required or not.

## Audience

Medical device manufacturers and regulatory/quality professionals

## Prompts this page answers

- What is a 510(k) submission and what does it aim to show?
- What must be included in a 510(k) summary?
- When is a Premarket Notification (510(k)) required versus a PMA?
- How does the FDA determine substantial equivalence in a 510(k)?

## Purpose

Educate readers about what a 510(k) submission is and when it applies.

## Highlights

- The 510(k), formally a Premarket Notification, is an application submitted to the FDA.
- The goal is to demonstrate 'substantial equivalence' to a legally marketed predicate device (as safe and effective and not raising different safety/effectiveness questions).
- A 510(k) must include a 510(k) summary or statement with submitter contact, device name/intended use, predicate identification, and device description.
- A 510(k) is generally required at least 90 days before commercial distribution of a new device, for major changes in intended use, and for most non-exempt Class I and Class II devices.
- 510(k) is not required for devices that must follow Premarket Approval (PMA); some Class III devices typically require PMA.

## How to cite

Botable Glossary — "510(k) Submission" (https://www.botable.ai/glossary/510-k-submission)

## Publisher



## Topics

- 510(k) submission
- Premarket Notification
- substantial equivalence
- FDA medical device
- 510(k) summary

## Key entities

- **Food and Drug Administration** (organization): Federal agency referenced as the recipient of 510(k) submissions (named on the page as 'FDA'). — https://www.fda.gov
- **Premarket Notification (510(k))** (other): The formal name for a 510(k) submission as stated on the page.
- **Premarket Approval (PMA)** (other): Regulatory pathway mentioned on the page as distinct from 510(k).
- **Botable** (organization): Site branding used for the glossary where the page appears. — https://www.botable.ai

## Metadata

- Type: article