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510(k) Consultants for FDA Clearance Success

If you are into a 510(k) submission, precision is key. At Elexes, our 510(k) expert consultants will chart your course through the entire 510(k) submission process, from product classification and predicate device selection to documentation and communication with the FDA. Startups or established manufacturers - we will ensure that your device has a clear track down the pathway to the market.

⦿ End-to-end 510(k) support

⦿ Customized strategies for traditional, special, and abbreviated submissions

⦿ Accelerated timelines without compromising on compliance

Why Choose Elexes as Your 510(k) Consultants?

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Navigating the FDA’s regulatory framework for Class II medical devices can be complex and time-consuming. Incorrect predicate device selection for 510(k) or missing documentation can delay your product launch by months. Our consultants at Elexes reduce your regulatory burden by managing every stage of the 510(k) submission with precision and insight.

We help you:

⦿ Identify optimal predicate devices

⦿ Prepare and organize compliant documentation

⦿ Align with FDA expectations for substantial equivalence

⦿ Avoid unnecessary delays due to RTA (Refuse to Accept) letters

Our Proven FDA 510(k) Submission Process

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With years of experience in handling successful 510(k) submissions, our step-by-step methodology ensures completeness, clarity, and compliance.

Our process includes:

⦿ Regulatory assessment based on product risk, claims, and classification

⦿ Predicate analysis and substantial equivalence justification

⦿ Preparation of all required sections of the 510(k) including 21 CFR Part 807.92

⦿ Risk management documentation per ISO 14971

⦿ Performance testing strategies and summary alignment

⦿ Post-submission FDA communication and response handling

Download Your 510(k) FDA Readiness Checklist PDF

Learn more about FDA’s 510(k) program here.

Types of 510(k) Submissions We Support

From routine to complex, our team supports all types of 510(k) pathways.

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Combination Products & Complex Devices

We coordinate with both CDRH and other FDA centers (e.g., CDER) as needed.

Traditional 510(k)

For standard devices where full data and predicate comparison are required.

Special 510(k)

Streamlined approach for modified devices where changes don't affect safety/performance.

Abbreviated 510(k)

Relies on recognized consensus standards and guidance documents.

510(k) for Software as a Medical Device (SaMD)

We help you comply with FDA software documentation, including Level of Concern and cybersecurity.

What Sets Elexes Apart from Other 510(k) Consultants

Deep Regulatory Expertise

Our team includes former FDA reviewers and regulatory professionals with 20+ years of experience in 510(k) filings.

Cross-Functional Collaboration

We coordinate with your R&D, QA, and manufacturing teams to ensure all data and documentation align with FDA expectations.

Quality-Driven Documentation

We prepare audit-ready documents including Device Description, Executive Summary, Performance Testing, and more.

Strategic Predicate Selection

Using structured equivalence analysis, we help identify the most appropriate predicate device for faster clearance.

Post-Submission Support

From additional information requests (AI Requests) to FDA meetings, we manage all communication.

Integrated Risk and Labeling Review

We integrate labeling and risk assessments to comply with both FDA requirements and ISO 13485.

QMSR & ISO 13485 Readiness

We align your 510(k) submission with FDA’s new QMSR requirements, harmonized with ISO 13485:2016. This ensures your quality system and design controls meet both FDA and global expectations.

Start Your FDA 510(k) Journey Today

Our consultants simplify compliance and reduce approval times with a roadmap tailored to your device and business goals.

Ready to Fast-Track Your FDA Clearance?

Let Elexes be your regulatory partner from concept to clearance. We make 510(k) submissions simple, structured, and successful.

FAQs

Frequently Asked Questions!

What is a 510(k) submission?

A 510(k) submission is a premarket notification required by the FDA for Class II devices, demonstrating that the device is substantially equivalent to a legally marketed predicate device.

How long does the 510(k) process take?

Most 510(k) submissions are reviewed within 90 calendar days, but actual timelines may vary depending on device complexity and FDA queries.

Can I submit a 510(k) for software devices?

Yes, SaMD and embedded software products can be submitted via 510(k), provided you meet FDA’s documentation and validation requirements.

Compliance Assurance

Stay compliant with industry regulations and standards.

Cost-effective

Achieve regulatory success with Elexes, all within your budget.

Why choose

Elexes for medical device regulatory & compliance services?

Quick Turn around

Experience timely results with our efficient services.

Confidentiality guaranteed

We offer 100% confidentiality understanding how critical the data is for you.

Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!

Our New Product Approval Service Corner

We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -

Global Regulatory Strategies

Creating a new medical product can be challenging in itself. Add a bit of regulatory formalities on top of it and it can become a nightmare for any medical device manufacturer to take care of it all at once. With our experience in working with different regulatory authorities around the globe, you can relax back while we create a successful global regulatory strategy for you through different services like - International regulatory strategies, FDA 513(g) request, product classification, Q-submission and international registration.

Pre-submission Support

Before you even consider submitting a new product for regulatory approval, it is essential that you have a strategy in place for determining the best pathway to get clearances in one-go. The good thing with us is that we will have you prepared for all your regulatory inspections. Right from preparing and conducting pre-submission mock meetings, creating proper regulatory strategy to evaluating ISO 13485 & compliance for your product, we will help you throughout.

Associated Regulatory Authorities.

We’ve More
Than 256+ Global Clients

The Best RA & QA Consultants

Clients Testimonials

Amazing Feedback About Our Services

Tom Birney

CEO Masterlink, Arizona

^“ Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms _“

Diane Bryant

CEO Novasignal, Los Angeles

^“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process. _“

Daniel Kinsey

President ViDava, Florida

^“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice. _“

Linda Pan

Sr. Exe Treedental, Hong Kong

^“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step. _“

Joshua Mink

Manager Outset Medical, California

^“Highly recommend Elexes! They always meet commitments and follow through on action items. _“

Michal Depa

CTO Jana Care, Massachusetts

^“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly. _“

Philip McFerran

MD Blackrock Pharma, England

^“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations. _“

Samip Shah

VP Regulatory AliveCor, California

^“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise. _“

Elizabeth W

Owner Liz Inc., Arizona

^“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time. _“