Regulatory

FDA 510(k) Clearance

Substantial equivalence pathway — done right the first time.

Representative work

Device classes & artefacts we support.

Laparoscopic surgical instrument — Class II 510(k)
Laparoscopic surgical instrument — Class II 510(k)
Balloon-catheter— Class II
Balloon-catheter— Class II
Diagnostic instrumentation
Diagnostic instrumentation
Insulin home use pump
Insulin home use pump

The problem

It takes six months and three RTA letters to fix an improperly completed 510(k). And we see this weekly.

Our solution

We develop your 510(k) similar to how you would develop a defense dossier; we include the strongest possible predicate selection, detailed substantial equivalency analysis, validated performance testing and reviewer friendly traceability.

Process

How we run this engagement.

  1. Predicate scan & substantial equivalence analysis

  2. Pre-Submission (Q-Sub) drafting & FDA meeting prep

  3. Performance testing plan (bench, biocompatibility, EMC, sterilisation)

  4. eSTAR-native authoring with reviewer traceability

  5. Response strategy for FDA requests (Additional Information)

Substantial equivalence pathway — done right the first time.

How we help

We build your 510(k) like a defence dossier: ironclad predicate selection, granular substantial equivalence comparison, validated performance data and reviewer-friendly traceability.

Category

Medical Device Regulatory

Discuss your FDA 510(k) Clearance program →

Ready to start?

Tell us about your program — we typically respond within one business day.

Book a free 30-min consult