Contact
← All workflows

510k Premarket Notification

Draft FDA 510(k) Submissions in Minutes, Not Hours

15 minutes with CaseMark

Fast lane

We have it from here.

Drop your documents and we'll handle the rest. Results delivered to your inbox.

1. Add your email so we know where to send the result.

2. Upload the files you want analyzed.

3. Run the workflow and we'll take it from there.

Need more context?

Scroll for the workflow details below if you want to review what this run handles, what documents help, and what the output looks like.

Want saved work, higher file limits, and a fuller workspace? Open the full CaseMark app instead.

Jump to detailsOpen casemark

Start here

Upload documents

The upload area is live as soon as your email is in place. Drag files in or browse from your device.

Workflow

510k Premarket Notification

Step 1 · Deliver to

Step 3 · Run workflow

Overview

CaseMark's 510(k) Premarket Notification skill drafts complete FDA submission packages demonstrating substantial equivalence to predicate devices under 21 CFR Part 807. Supporting Traditional, Special, and Abbreviated pathways, the AI generates every required section from cover letters and Form 3514 to detailed device descriptions and structured equivalence comparisons. Regulatory teams can produce comprehensive first drafts in a fraction of the time typically required for manual preparation.

Preparing a 510(k) premarket notification is one of the most time-intensive tasks in medical device regulatory affairs. Teams spend weeks manually drafting device descriptions, building comparison tables, populating FDA forms, and ensuring every section cross-references correctly — all while keeping pace with evolving FDA guidance and formatting requirements.

CaseMark automates the heavy lifting of 510(k) drafting by analyzing your device technical file and predicate information to generate a complete, structured submission package. The AI ensures consistent terminology, comprehensive substantial equivalence analysis, and proper section organization so your regulatory team can focus on scientific review and strategic decisions rather than document assembly.

How it works

  1. 1. Upload your device technical file, predicate device information, and performance data

  2. 2. AI analyzes your device against the predicate and structures the full 510(k) submission

  3. 3. Review and customize each section including the substantial equivalence comparison

  4. 4. Export the complete submission package in your preferred format (DOCX, PDF)

What you get

  • Cover Letter to CDRH

  • FDA Form 3514 Completion

  • Device Description

  • Substantial Equivalence Comparison

  • Performance Data Summary

  • Proposed Labeling Summary

What it handles

  • Complete 510(k) submission package generation across Traditional, Special, and Abbreviated pathways

  • Structured substantial equivalence comparison tables with predicate device analysis

  • Automated FDA Form 3514 population with classification and registration data

  • Comprehensive device description drafting with materials, software, and sterility sections

  • Performance data organization including biocompatibility and bench testing summaries

  • Cover letter drafting addressed to appropriate CDRH division

Required documents

  • Device Technical File

    Engineering drawings, materials lists, specifications, software architecture, and other technical documentation for the subject device

    .pdf, .docx

  • Predicate Device Information

    Predicate device details including trade name, manufacturer, 510(k) number, clearance date, and available technical specifications

    .pdf, .docx

  • Performance & Testing Data

    Bench testing results, biocompatibility data (ISO 10993), clinical evidence, and literature references supporting substantial equivalence

    .pdf, .docx, .xlsx

Supporting documents

  • Proposed Labeling Materials

    Instructions for use, package inserts, patient materials, and packaging artwork for the subject device

    .pdf, .docx

  • Prior FDA Correspondence

    Any pre-submission meeting minutes, FDA feedback letters, or prior 510(k) submissions related to this device

    .pdf, .docx

  • Standards & Guidance References

    Recognized consensus standards, FDA guidance documents, or special controls applicable to your device classification

    .pdf, .docx

Why teams use it

Reduce 510(k) drafting time from weeks to hours with AI-generated submission packages

Ensure structural completeness with automated section generation aligned to CDRH requirements

Produce rigorous substantial equivalence comparison tables that systematically address every device characteristic

Maintain consistency across submission sections with unified terminology and cross-referencing

Questions

Which 510(k) pathways does CaseMark support?

CaseMark supports all three FDA 510(k) pathways: Traditional, Special, and Abbreviated. The AI tailors the submission structure and content requirements based on your selected pathway, ensuring the appropriate level of detail and documentation for each.

How does CaseMark handle the substantial equivalence analysis?

CaseMark generates structured comparison tables that map your device's characteristics against the predicate device across intended use, technological characteristics, performance data, and safety profiles. The AI identifies similarities and differences, flagging areas that require additional justification or testing data.

Can CaseMark draft submissions for software-enabled or AI/ML medical devices?

Yes. CaseMark includes dedicated sections for software architecture, cybersecurity documentation, and AI/ML components when applicable. The AI follows current FDA guidance on software as a medical device (SaMD) and predetermined change control plans.

Does CaseMark replace the need for a regulatory affairs specialist?

CaseMark dramatically accelerates the drafting process but is designed to augment regulatory professionals, not replace them. The AI produces a comprehensive first draft that your regulatory affairs team should review, refine, and validate before submission to the FDA.

What information do I need before using CaseMark for a 510(k)?

You'll need your device technical file (drawings, materials, specifications), predicate device details (trade name, manufacturer, K-number), performance and testing data (bench testing, biocompatibility results), proposed labeling, and your FDA establishment registration information.

How current is CaseMark with FDA guidance documents?

CaseMark's 510(k) drafting skill is built on the regulatory framework of 21 CFR Part 807, Subpart E, and incorporates current CDRH submission formatting requirements. Your regulatory team should always verify alignment with the latest FDA guidance documents applicable to your specific device classification.

Related

Adverse Event Reporting Policy

Draft FDA-Compliant Adverse Event Policies in Minutes

Anti-Money Laundering (AML) Compliance Program

Draft AML Compliance Programs in Minutes, Not Days

Antitrust Investigation Summaries

When businesses are subject to antitrust investigations, these summaries detail the allegations, the investigative process, and the outcomes or ongoing status. They are vital for corporate compliance and regulatory affairs.