What is 510k

It is formally called a Pre-market Notification. A k contains detailed technical, safety, and performance information about a medical device. The documentation must demonstrate the device in question is "substantially equivalent" to a predicate device i.

The FDA must review the k and "clear" your device before you can legally sell or distribute it in the United States. If you cannot determine the classification for your product, you can submit a g , which is a written request to the FDA seeking classification confirmation. Additionally, once you have submitted and find out you need to make changes it could waste valuable time.

The FDA timeframe for review is 90 calendar days. The manufacturer must then list their product with the FDA and register their company if this is the first time of selling to the US market. Follow Us:. Thank you! Meet our Team Why Proxima Careers.

Glossary of Terms. View All glossary About the Author. Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.

De Novo. Predicate Device. Premarket Approval PMA. Related FAQs:. How do you submit a k using the safety and performance based pathway? How do you determine substantial equivalence for a k submission? What is the typical review process of a SIR? As such, medical device manufacturers must complete the following steps from the outset of the product development process:. The FDA divides medical devices into three classes that correspond generally to their risk profile:.

Class I : These devices are simple, with minimal risk to the user. They are subject to the general regulatory controls of medical devices and typically do not require any premarket submissions. Class II : Devices in this class pose a moderate level of risk to the user, and all of them require a premarket notification k submission before they can be legally marketed. Items like pregnancy testing kits, intravenous kits, sutures, and powered wheelchairs could fall into this category.

These devices are important for health care, but a malfunction would be unlikely to cause critical harm to a patient. Class III : Class three devices are typically either implanted medical devices or those that sustain life, like an implantable pacemaker, blood vessel stents, or other implanted device. Devices in this class are seen as the highest risk for patients, as any problems with the device could lead to significant adverse outcomes for the patients.

Each of these submission types result in a determination by FDA that clears [ k ], approves [PMA], or grants [de novo] marketing rights to the successful submitter.

The most commonly made submissions are described in more detail below. Each person who wants to market in the U. A k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective substantially equivalent to a legally marketed device that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices predicates and make and support their substantial equivalency claims.