FDA 510(k) Premarket Notification & Clearance Consulting

As a dedicated medical device consultancy, we structure your USFDA 510(k) (510 k) around the substantial equivalence decision FDA must make. Classification, predicate eligibility, technological differences, testing evidence, and labeling are aligned before the eSTAR submission is built.

Discuss Your 510(k) Strategy

What Is a 510(k)?

A 510(k) is a premarket submission used to demonstrate that a device is substantially equivalent to an appropriate legally marketed predicate device before commercial distribution in the United States. For many Class II devices, and certain devices in other classes, this is the primary premarket pathway.

When Is a 510(k) Typically Needed?

When introducing a new device type that is subject to premarket notification

When the proposed device can potentially demonstrate substantial equivalence to a legally marketed predicate

When certain significant changes to an already cleared device may trigger a new 510(k) assessment

When changes to technology, materials, software, sterilization, labeling or performance may affect safety or effectiveness

How We Build the 510(k)

We do not begin by filling the eSTAR. We first establish whether the regulatory strategy can withstand FDA review. Our assessment covers classification, product code, intended use, indications for use, predicate eligibility, technological characteristics, FDA guidance, consensus standards and the evidence required to support differences from the predicate:

Classification and pathway confirmation

Predicate research and substantial equivalence strategy

Testing and standards strategy

Biocompatibility, sterilization, packaging and shelf-life evidence

Software, cybersecurity, electrical safety and EMC where applicable

Human factors and IVD performance evidence where applicable

eSTAR preparation and technical consistency review

FDA Interactive Review and Additional Information response support

Reviewer-Level Consistency Check

Before submission, we challenge whether the same regulatory position is maintained across: Indications for Use → Device Description → Predicate Comparison → Risk → Testing → Labeling. A technically sound report can still create a deficiency if it conflicts with another section of the dossier.

Our Difference

Evidence-Driven Substantial Equivalence

We build the regulatory and evidence strategy that supports the substantial equivalence decision — not just the submission file.

Key 510(k) Elements

Mandatory eSTAR electronic format
Predicate comparison & SE rationale
Non-clinical bench, biocompatibility & safety testing
Software / Cybersecurity documentation

Planning a 510(k) Clearance?

Engage senior FDA regulatory experts to de-risk your submission strategy.

Discuss 510(k) Strategy

Ready to Build Your 510(k) Submission?

Partner with NKB Regovanta to create a defensible, reviewer-proof FDA dossier.

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