3P510(k) Review

– Skip the Line to FDA Clearance

Cut approval times by over a year and bring your Class II device to market in as little as 60 days

What is FDA’s Third-Party Review Program?

The 510(k) Third Party Review Program provides medical device manufacturers with a voluntary alternative review process, in which accredited Third Party Review Organizations (3P510k Review Organizations), such as BeanStock Consulting, are allowed to review select medical devices while still maintaining FDA oversight.

The FDA Third-Party Review Program allows you to:

Fast-track your clearance by getting FDA review and recommendation in as little as 60 days, compared to the 31-month median for traditional submissions.

Save time and resources by working with 1 of only 7 FDA-recognized review organizations worldwide, experienced in over 250 Class II product codes.

Reduce regulatory uncertainty with early FDA-equivalent feedback with a dedicated reviewer that minimizes delays.

What’s the process

We make the 3P510(k) process simple—early interactions with the FDA, conducting the FDA-equivalent review,
providing comprehensive requests for information, and delivering a recommendation to and obtaining a
response from the FDA in as little as 60 days.

Learn more about the FDA 3P510K program

Discover how the FDA’s Third-Party Review Program can dramatically shorten clearance times for eligible Class II devices by leveraging accredited reviewers like BeanStock Consulting to perform FDA-equivalent reviews.

Determine if your device qualifies

Find out whether your device’s classification and product code are eligible for Third-Party review—roughly 50% of Class II product codes currently qualify, including many in-vitro diagnostics and digital health technologies.

Understand the submission process

See how the 3P510(k) pathway works—from initial eligibility review through submission assembly, third-party evaluation, and final FDA clearance recommendation.

BeanStock Ventures (BSV) declares that it protects against the use, in carrying out any review of a 510(k) submission and initial classification of a device of any officer or employee and maintains compliance with requirements relating to financial conflicts of interest.

“We didn’t think FDA clearance could happen this quickly. BeanStock Ventures demonstrated a deep technical understanding of our device—even with its architectural complexity and integration with third-party medical devices. Their 3P510(k) review process was smooth, efficient, and supported by fast communication and clearly defined, actionable comments. Their support enabled us to achieve clearance in just 60 days.”

Anika Uhde

CEO, Medical Templates AG
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We Have the Answers to
Your Top Questions

What is the FDA Third-Party Review Program?

It’s an FDA initiative that allows accredited organizations like BeanStock Consulting to review certain Class II medical devices and submit clearance recommendations directly to the FDA, significantly reducing the review timeline.

How much faster is the 3P510(k) process compared to traditional review?

Traditional FDA reviews can take over 31 months, but with BeanStock Consulting as your third-party reviewer, most eligible devices achieve clearance in as little as 60 days.

How do I know if my device qualifies?

The FDA maintains a list of hundreds of Class II product codes eligible for Third-Party review. BeanStock Consulting can quickly assess your product’s classification and eligibility during an initial free-consultation.

Is the review process different from a standard FDA review?

The requirements and rigor are the same—the difference is speed. BeanStock Consulting allocates dedicated resources during the lifetime of your review and performs an FDA-equivalent review, raises issues quickly, and delivers a clearance recommendation directly to the FDA for consideration, reducing back-and-forth and delays.

Don’t see what you’re looking for? Reach out to our team

Clear your device in as little as 60 days

As 1 of only 7 FDA-accredited third-party review organizations, our 3P510(k) service helps you bypass traditional FDA delays, offering a faster route to market with expert-reviewed FDA approved submissions for over 250 product codes

Expert Help From Start to Finish

A proven system to accelerate your time to market

Regulatory Strategy

Just beginning, or require clarity on your regulatory pathway? Start with our foundational regulatory strategy services to chart the most effective course to market readiness.

QMS & Technical Documentation Support

Ensure your QMS is in place and your DHF is complete with services like audits, assessments, design reviews, and documentation creation or updates.

FDA Submission Support

Navigate the entire FDA submission process with clear guidance on Q-Submission, eStar review or assembly, FDA additional information requests, or deficiencies.

Post-Market Support

After approval, get support with company and product registrations and ongoing compliance so your product stays current with FDA requirements.

Agilent
scinogy
ionpath
cardiac
modular medical
Medical Templates AG
zoetis
illumina
grail
CooperSurgical
alcon
bvimedical
Topcon Healthcare SEA
EMED Technologies
ipill dispenser
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Let’s Build Your Path
to Approval

We’ll work with you to develop a clear plan that keeps things moving, helps you avoid delays, and gets your product ready for FDA approval.