510K SUBMISSION CONSULTANTS
FDA MEDICAL DEVICE REGULATORY CONSULTING
We help you navigate US commercialization. We are global specialists in 510(k) Submissions, De Novo classifications, Pre-submissions, Establishment Registration, and we operate as your US Agent.
510(k) & De Novo
US Agent
(English/Spanish)
GLOBAL OPPORTUNITY 2026
The US medical technology market will exceed $230 Billion.
Demand knows no borders. Do not let regulatory bureaucracy stall your international expansion. SANRUBIO will help you break down these barriers and clear your path to the FDA and the US market.
+5 Years
of Global service
Proven track record achieving 510(k) clearances and successful registrations for companies across multiple continents.
+10 Years
of Regulatory Expertise
Technical consultants at your disposal. Specialists trained in medical device regulations.
Physical Presence
US Headquarters and LATAM Representation
Physical presence in the US, communicating with you in your language without technical or cultural barriers.
OUR FIRM
Your Strategic Partner in Regulatory Affairs
We drive the global expansion of medical device manufacturers. At Sanrubio Medical Devices Consulting, we are a specialized FDA medical device regulatory consulting firm. We facilitate your commercial clearance through technical files for 510(k) submissions, De Novo classifications, and Pre-submission management.
We operate as your trusted partner and official US Agent. We manage the entire regulatory lifecycle: from FDA medical device establishment registration to maintaining your Device Listing and ensuring compliance with Quality Management Systems (QMS - 21 CFR 820)
"In an industry where technical rigor and patient safety are non-negotiable, we provide the regulatory certainty your company needs to conquer the US market while minimizing the risk of FDA rejection."
Technical Rigor
Confidentiality
Files Prepared for FDA Review
Our technical submissions strictly comply with the eSTAR formats required by FDA reviewers.
Submissions in eSTAR Format
Custom Regulatory Strategy
OUR SERVICES
Your Outsourced Regulatory Affairs Department
From initial device classification to final clearance. We minimize the risk of FDA rejection by generating fully compliant technical submissions.
510(k) Submission
End-to-end management of your 510(k) submission. We draft, prepare in eSTAR format, and submit your dossier to FDA reviewers to obtain your 510(k) clearance.
De Novo Submission
We determine if your novel technology requires a De Novo classification or qualifies for faster clearance pathways by evaluating predicate devices.
Establishment Registration
We navigate the FURLS portal to handle your FDA medical device establishment registration and Device Listing, a mandatory process for exporting to and commercializing in the US.
US Agent Services
Legal Requirement for Non-US Manufacturers We act as your physical US Agent, receiving urgent communications and FDA inspection notifications.
Unsure which regulatory pathway your device requires?
Don't risk time and capital on incorrect classifications. Our technical team will conduct a preliminary review of your device at no cost.
How we work
Contact us
Personalized consulting tailored to your objectives. Contact us to develop a custom regulatory strategy.
Preliminary Assessment
Review your technical documentation to identify gaps and ensure alignment with FDA and international standards.
Submission
Our team manages the preparation and submission of the necessary documentation, ensuring a streamlined process in full compliance with applicable regulations.
FINANCIAL TRANSPARENCY
Official FDA Fees 2026
Discover the exact FDA fiscal year fees. As your strategic partner, we don't just help you with compliance - we also help you secure substantial discounts.
MANDATORY ANNUALLY
Establishment registration
FDA user fee for facilities that export or market devices, regardless of their size.
$11,423 USD
Payment is required every year (Oct-Dec).
FURLS Registration
Device listing
Save 75% on FDA Fees
510(K) Submission
STANDARD FEE
$26,067 USD
For Class II medical devices (non-exempt and non-novel).
YOUR SMALL BUSINESS FEE*
$6,517 USD
BUDGET IMPACT
$19,550 in savings
*We manage your FDA Small Business Determination for businesses with annual sales below $100M USD, ensuring this crucial cost-saving for your project.
01
What is a 510(k) submission and when do you need one for your medical device?
The 510(k) is a regulatory clearance process that requires demonstrating your device is substantially equivalent to an already approved one (known as a predicate device). It primarily applies to moderate-risk devices (Class II) and certain Class I devices.
02
What happens if the FDA rejects my 510(k) submission?
You may receive a “Not Substantially Equivalent” (NSE) letter. This is not the end of the road, you can revise and resubmit a new 510(k) application or choose to apply through the De Novo pathway - if applicable.
03
When should I use the De Novo pathway instead of the 510(k)?
The De Novo process is designed for innovative devices without a predicate device but with low to moderate risk. It’s ideal when your technology has no equivalent currently on the market.
04
How long does it take to get FDA approval?
510(k) Submission: 3 to 6 months
De Novo Submission: 6 to 12 months
Establishment registration: 1 to 5 business day
These timeframes are estimates and may be affected by requests for additional evidence or FDA workload.
