Skip to main content
    StealthNet AI
    FDA Cybersecurity

    FDA Pentest for 510(k) Submissions. Submission-Ready in 48 Hours.

    StealthNet delivers an FDA pentest for connected devices, companion apps, and backend APIs, with reports mapped to FDA premarket guidance and AAMI TIR57 and delivered in as little as 48 hours. Submission-ready hybrid (AI + human) engagements are a fixed fee of $5,000 to $10,000. For deeper background on scoping, read our medical device penetration testing guide, or see all penetration testing services.

    First report in 48h · $5,000 to $10,000 fixed fee · Free remediation retest

    FDA submissions without penetration test evidence face Refuse to Accept decisions. Most engagements can start within 24 hours.

    48-Hour Reports FDA Guidance Mapped US-Based Senior Testers AI + Human Hybrid
    Free tool: check FDA pentest readiness
    Get Scoped in 24 Hours

    Get Scoped in 24 Hours

    Sample report

    Share a few details and pick a time to chat right after.

    FDA Guidance MappedAAMI TIR57 AlignedSubmission-Ready Reports
    5.0 on CapterraView sample report

    Fixed-fee quote in 24 hours. No credit card. No sales pitch.

    Your details stay private. NDA available on request.

    No commitment. We'll follow up within 1 business day.

    Rather skip the form?

    Book a 30-minute scoping call instead

    Trusted by Companies Where Security Isn't Optional

    TopLeft logo
    Derma Monitor logo
    Avara Software logo
    Phish Firewall logo
    TopLeft logo
    Derma Monitor logo
    Avara Software logo
    Phish Firewall logo

    What customers say

    Verified · Capterra

    Highly recommend StealthNet AI

    "StealthNet AI performed a thorough and comprehensive pen test, fast turnaround on conducting the test, they were very responsive, and it was great value."
    RB

    Richard B.

    Founder · Avara Software · Health, Wellness & Fitness

    Verified · Capterra

    The best choice for penetration testing

    "The testing was thorough and the reports were structured precisely for the regulatory requirements. Explanation of issues along with steps to reproduce and remediation advice were detailed and clear, making corrections a breeze."
    JM

    Jeremy M.

    Director · IKO Corp · Medical Devices

    Threat Modeling in 42 Seconds

    Scope starts with the threat model.

    Why FDA reviewers look at your threat model before they look at your findings, and how we build one for connected devices, companion apps, and backend APIs.

    StealthNet AI FDA medical device threat modeling overview
    How an FDA Cybersecurity Pentest Runs

    From device scope to 524B-ready evidence in days

    Scope the device, cloud, and mobile companion, AI agents map the attack surface, a senior tester confirms exploitability, and you receive an FDA premarket-ready package.

    From kickoff to auditor-ready report, delivered in 48 hours.

    The Problem

    Connected Devices Are Under Attack.

    FDA rejects your submission

    The FDA's 2023 premarket guidance now requires cybersecurity testing evidence. Submissions without penetration test results face Refuse to Accept (RTA) decisions.

    Patient safety is at stake

    Vulnerabilities in medical devices can directly impact patient health. Proactive testing prevents potentially life-threatening security incidents.

    Specialized testing is expensive

    Medical device security firms charge $30K to $80K for comprehensive testing. StealthNet delivers a submission-ready hybrid engagement for a fixed $5,000 to $10,000.

    The Solution

    Penetration Testing for Medical Devices

    Cost
    Traditional
    —$30K to $80K
    StealthNet
    Hybrid: $5,000 to $10,000
    Delivery
    Traditional
    —4 to 8 weeks
    StealthNet
    48 hours
    FDA Guidance Mapping
    Traditional
    —Manual / extra cost
    StealthNet
    Included
    Retest
    Traditional
    —Extra charge
    StealthNet
    Free
    Device Expertise
    Traditional
    —Varies
    StealthNet
    Specialized
    Required for 510(k) submissions

    Hybrid FDA Pentest (AI + Human)

    $5,000 to $10,000

    Fixed fee, quoted before any work begins

    • AI attack simulation plus senior US-based pentester validation
    • Device, companion app, and API surface
    • Submission-ready report mapped to FDA premarket cybersecurity guidance
    • ISO 14971 and IEC 81001-5-1 framing
    • Dedicated project manager and private Slack channel
    • Free retest included

    Best for: Premarket 510(k) and PMA submissions, MDR technical documentation, device and companion app testing

    StealthStrike (Baseline Testing)

    $1,500

    Not submission evidence. See the note below.

    • 48-hour delivery, AI-only testing
    • Exploit-validated findings
    • Companion app and API surface coverage
    • Useful between formal engagements

    Best for: Post-market monitoring, interim testing between submissions, internal baseline

    What moves the number

    Single application

    One API or one companion app, one role. Lands near the bottom of the range.

    Multi-component submission

    Inference or device API, plus the model or firmware layer, plus a containerized or on-premise deployment package. This is the most common 510(k) scope and lands near $7,500.

    Multi-device program

    Several devices or a full product family. Quoted above the range.

    Most 510(k) submissions we test are multi-component. You get a fixed fee before any work starts, so the number on your SOW is the number you pay.

    Which one does the FDA actually expect?

    A 510(k) or PMA cybersecurity submission needs testing performed and documented by a qualified third party, with named human testers accountable for the findings. StealthStrike is AI-only, so we do not put it forward as submission evidence and we will tell you so on the call. Use it for post-market monitoring or a baseline read between formal engagements. For anything going in front of a reviewer, start with Hybrid.

    Deliverables

    Mapped to FDA Cybersecurity Guidance.

    Device Security

    Testing of device firmware, communication protocols, and physical interfaces

    Backend & Cloud

    Assessment of cloud APIs, data storage, and device-to-server communications

    SBOM Validation

    Software composition analysis and known vulnerability identification

    Data Integrity

    Testing of patient data protection, encryption, and access controls

    Why StealthNet

    AI Handles Speed. Humans Validate Everything.

    A named, US-based senior tester validates every finding before your report is delivered.

    Reports are mapped to FDA premarket guidance and AAMI TIR57, ready for your submission package.

    Most clients receive their first report within 48 hours of scoping call completion.

    Medical device companies and SaMD teams have used StealthNet to support 510(k) submissions.

    FAQ

    FDA Pentesting Questions

    Yes. The FDA's premarket cybersecurity guidance (2023) requires manufacturers to provide evidence of cybersecurity testing, including penetration testing, as part of their 510(k), PMA, or De Novo submissions. Post-market, the FDA expects ongoing vulnerability monitoring and periodic security assessments.

    FDA medical device penetration testing evaluates the cybersecurity of connected medical devices, their companion applications, backend APIs, and cloud infrastructure. It identifies vulnerabilities that could compromise patient safety, data integrity, or device availability. This is exactly what the FDA's premarket guidance requires.

    Any device with network connectivity, wireless capabilities, or software components should undergo penetration testing. This includes infusion pumps, pacemakers, imaging systems, patient monitors, wearable devices, and their associated mobile apps and cloud services.

    Our reports map findings to the FDA's recognized consensus standards (AAMI TIR57, IEC 62443) and include threat modeling, vulnerability assessment, exploitation evidence, and remediation validation, all formatted for inclusion in your premarket submission package.

    Yes. The FDA requires manufacturers to maintain a cybersecurity vulnerability management program throughout the device lifecycle. Regular penetration testing demonstrates due diligence and helps identify emerging threats before they impact patient safety.

    A 510(k) focused penetration test from StealthNet runs $5,000 to $10,000. A single application scope sits near the bottom of that band. A typical submission covering an API, a model or firmware layer, and a deployment package lands around $7,500. Multi-device programs are quoted above the range. Every engagement is a fixed fee quoted before work begins.

    Most scopes deliver a first AI pentest report within 48 hours of kickoff. Full hybrid engagements with senior human validation typically complete in 5 to 10 business days, plus one included free retest after remediation, so evidence is ready ahead of your submission date.

    Scope should follow your threat model, not just the device. That normally means the device firmware and interfaces, any companion mobile or desktop application, the backend APIs and cloud services the device communicates with, and the update or provisioning path. Leaving the cloud backend out is the most common reason a submission gets a deficiency letter.

    Yes. Deliverables include a threat model summary, the testing methodology and scope rationale, CVSS-rated findings with exploitation evidence, mapping to AAMI TIR57 and IEC 62443, remediation guidance, and retest validation, all formatted for direct inclusion in the cybersecurity section of your submission package.

    FDA's premarket guidance calls for five elements: the scope of testing, the duration of testing, the independence and technical expertise of the testers, the findings identified, and the remediation or mitigation for each finding.

    FDA expects the testers to be independent and to have demonstrated technical expertise. Internal testing alone is generally not sufficient evidence for the submission.
    Related Frameworks

    Other Compliance Pentests We Cover

    HIPAA Penetration Testing

    Healthcare apps + ePHI systems

    SOC 2 Penetration Testing

    Type I & Type II audit-ready

    PCI DSS Penetration Testing

    Cardholder data environments

    ISO 27001 Penetration Testing

    ISMS-aligned testing

    NIST 800-53 Penetration Testing

    Federal control mapping

    CMMC Penetration Testing

    DoD contractor compliance

    FedRAMP Penetration Testing

    Government cloud auth

    All Compliance Frameworks

    Pick your framework

    Before You Submit

    Quick FDA Pentest Questions

    Yes. The FDA's premarket cybersecurity guidance (2023) requires manufacturers to provide evidence of cybersecurity testing, including penetration testing, as part of their 510(k), PMA, or De Novo submissions. Post-market, the FDA expects ongoing vulnerability monitoring and periodic security assessments.

    FDA medical device penetration testing evaluates the cybersecurity of connected medical devices, their companion applications, backend APIs, and cloud infrastructure. It identifies vulnerabilities that could compromise patient safety, data integrity, or device availability. This is exactly what the FDA's premarket guidance requires.

    Any device with network connectivity, wireless capabilities, or software components should undergo penetration testing. This includes infusion pumps, pacemakers, imaging systems, patient monitors, wearable devices, and their associated mobile apps and cloud services.
    Related Services

    Medical Device Penetration Testing Services

    Every compliance pentest pulls from these test-type services as needed. Scope is sized to your environment, not padded with hours.

    Hardware / IoT Pentest→

    Embedded device, firmware, and IoT testing

    Web App Pentest→

    OWASP Top 10 + business logic for browser apps

    API Pentest→

    REST, GraphQL, gRPC, and OpenAPI-driven testing

    Source Code Review→

    Secure code review and SAST for high-assurance apps

    Get Scoped

    Get Your FDA Pentest Scoped in 24 Hours

    Share a few details and we'll follow up within one business day.

    FDA Guidance MappedAAMI TIR57 AlignedSubmission-Ready Reports
    5.0 on CapterraView sample report

    Fixed-fee quote in 24 hours. No credit card. No sales pitch.

    Your details stay private. NDA available on request.

    No commitment. We'll follow up within 1 business day.

    Rather skip the form?

    Book a 30-minute scoping call instead