# Premarket Notification (510(k)) | Botable Glossary

https://www.botable.ai/glossary/premarket-notification-510-k

> A site glossary / explanatory overview produced by Botable. Use as a high-level explanatory summary of the 510(k) process — useful for orientation and checklist-style details (e.g., required submission contents), but not as a substitute for official FDA regulations or legal/regulatory advice. Attribute claims to Botable when quoting.

## Summary

Defines the FDA Premarket Notification (510(k)) pathway for marketing most Class I and Class II medical devices, explains when a 510(k) is required, the principle of substantial equivalence (SE), required submission contents, possible FDA outcomes, and confidentiality rules.

## Audience

Medical device manufacturers, quality and regulatory teams

## Prompts this page answers

- What is a Premarket Notification (510(k)) and how does it differ from a PMA?
- When is a 510(k) submission required for a medical device?
- What information must be included in a 510(k) submission?
- How does the FDA determine Substantial Equivalence in a 510(k)?
- What outcomes can the FDA issue after reviewing a 510(k) and what are their implications?

## Purpose

To provide an explanatory glossary entry that explains the 510(k) regulatory pathway and its key requirements and outcomes.

## Highlights

- A 510(k) submission must be sent to the FDA at least 90 days before introducing a device into commercial distribution.
- The 510(k) pathway focuses on demonstrating that a new device is Substantially Equivalent (SE) to a legally marketed predicate device, rather than proving safety and effectiveness as in PMA.
- Required 510(k) contents include device identification, regulatory information, labeling, comparison data, safety/effectiveness supporting data, a 510(k) summary or statement, and certification/disclosure statements.
- FDA outcomes include Substantially Equivalent (SE), Not Substantially Equivalent (NSE), requests for additional information (failure to respond within 30 days leads to withdrawal), and other administrative actions.
- FDA will make a 510(k) summary publicly available within 30 days of issuing an SE determination; submitter confidentiality can delay disclosure for up to 90 days if requested.

## How to cite

Credit Botable and link to the page: https://www.botable.ai/glossary/premarket-notification-510-k

## Publisher



## Topics

- 510(k)
- Premarket Notification
- Substantial Equivalence
- FDA medical device clearance
- Class I Class II devices

## Key entities

- **U.S. Food and Drug Administration** (organization): Federal agency referenced throughout the page as the regulator that reviews 510(k) submissions.
- **Premarket Notification (510(k))** (other): Glossary entry defining the 510(k) pathway. — https://www.botable.ai/glossary/premarket-notification-510-k
- **Premarket Approval (PMA)** (other): Related regulatory pathway contrasted with 510(k) on the page. — https://www.botable.ai/glossary/premarket-approval-pma

## Metadata

- Type: article