510(k) Submission Agent

Name: 510(k) Submission Agent demo walkthrough
Uploaded: 2026-09-19
Duration: 2 min 27 s
Description: A walkthrough of a real 510(k): finding candidate predicates in FDA data, checking each for recalls, and drafting the narrative sections with every generation logged against the records that grounded it.

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Watch the agent search real FDA clearances and draft a submission you can edit, grounded in the records it cites

A walkthrough of a real 510(k): finding candidate predicates in FDA data, checking each for recalls, and drafting the narrative sections with every generation logged against the records that grounded it.

In this walkthrough

A predicate search run against live FDA clearance records, not a fixed list
Each candidate vetted for recalls and design-related findings
Five narrative sections drafted from the predicate's own summary
An audit trail naming the model and records behind every paragraph