A 510(k) submission is a premarket notification filed with the U.S. Food and Drug Administration (FDA) to demonstrate that a medical device is safe, effective, and substantially equivalent to a legally marketed predicate device. This process is essential for most Class II and select Class I devices before entering the U.S. market.

The first step in preparing a 510(k) submission is identifying a suitable predicate device—one that is legally marketed in the U.S. and shares similar intended use and technological characteristics. The submitter must then compile a comprehensive technical file to compare the new device against the predicate.

A standard 510(k) includes an administrative cover sheet (FDA Form 3514), a Truthful and Accuracy Statement, and a 510(k) Summary or Statement. The core of the submission comprises detailed device descriptions, including design, materials, functions, and technological specifications. It must also include labeling information, such as Instructions for Use and marketing materials.

Performance testing is crucial. Depending on the nature of the device, this may involve bench testing, biocompatibility data, sterilization validation, and, if necessary, clinical data. Risk analysis per ISO 14971 is also often included to support the device’s safety profile.

A substantial equivalence discussion is central to the 510(k). It compares the subject device with the predicate in terms of intended use, design, and performance, showing that any differences do not raise new questions of safety and effectiveness.

Once submitted, the FDA typically reviews a 510(k) within 90 calendar days. The agency may issue an Additional Information (AI) request during the review process. Once cleared, the device can be legally marketed in the U.S. under the specific indications and claims reviewed.

Successful 510(k) clearance ensures regulatory compliance and builds trust with healthcare providers and patients. It also lays the foundation for future product iterations and market expansion.