Overview of 510 K
To market a medical device in the United States, manufacturers are often required to submit a premarket notification (510(k)) to the US FDA, demonstrating that the device is as safe and effective as a legally marketed device.
A 510(k) submission is generally required for Class II devices, and for certain Class I and Class III devices.
Manufacturers, foreign exporters, US agents of foreign manufacturers, and specification developers must comply with this requirement when introducing devices into the US market.
Repackers and relabelers who significantly modify labeling or operations must also submit a 510(k) application.
Types of 510 K Submissions
- Traditional 510(k): The standard submission method for new devices.
- Special 510(k): For modifications to a previously cleared device that do not affect intended use or fundamental technology.
- Abbreviated 510(k): For devices with established guidance documents, special controls, or recognized standards.
- Quik 510(k) Pilot: A streamlined FDA program for select moderate-risk devices using electronic submission tools.
Advantages
- Demonstrates substantial equivalence to legally marketed devices
- Provides regulatory pathway for US market entry
- Supports device safety, effectiveness, and compliance
- Access to FDA electronic submission systems (eSubmitter)
Maven Expertise in 510 K
- Preparation and aggregation of 510(k) submissions
- eSubmission support and FDA communication
- Assessment of substantial equivalence with predicate devices
- Device listing and FURLS database management
- Up-to-date guidance on FDA regulatory requirements
- Timely submission and handling of FDA inquiries
Maven Advantage
- Specialized regulatory team for 510(k) submissions
- Proven track record of successful FDA clearances
- Expert guidance on selecting the appropriate 510(k) type
- Comprehensive support from submission to post-clearance
