Premarket Notification 510(k) — FDA Clearance
Most Class II medical devices require FDA 510(k) clearance before commercial distribution in the U.S. LMG supports device manufacturers with 510(k) strategy, preparation, and submission.
510(k) Premarket Notification Services
A 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Submitters must compare their devices to one or more similar legally marketed devices and make and support their substantial equivalency claims. The legally marketed device(s) to which equivalence is drawn is commonly known as the “predicate.”
LMG can assist you in preparing your Traditional, Abbreviated, or Special 510k submission to FDA.
Our FDA 510K Submission service includes:
- Identification of device class, product code, and regulation number
- Identification of predicate device
- Identification of 510k test requirements
- Identification testing lab
- Preparation of 510k documents
- Submission of 510k document to FDA
- Communicate to FDA on behalf of our client
- Prepare clarifications to questions from FDA
- Assistance in the transfer of 510k review fees to the FDA
- Assistance in Establishment registration with FDA
- Assistance in Device Listing with FDA
Device Classification
Identification of your device's FDA product code, device class, and applicable regulation — the starting point for all 510(k) pathway decisions.
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Predicate Device Analysis
Identification and analysis of suitable predicate devices for your 510(k) — the foundation of substantial equivalence and the most critical element of a successful submission.
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510(k) Submission
Complete preparation of your Traditional, Abbreviated, or Special 510(k) submission — including Device Description, Intended Use, Substantial Equivalence, Performance Testing, and Labeling sections.
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FDA Interaction Support
Preparation for pre-submission (Q-Sub) meetings with FDA, responses to Additional Information (AI) requests, and guidance throughout the FDA review process.
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A Proven Track Record of FDA 510(k) Clearances
Our history of success is public record. Click any number to verify directly on the official FDA 510(k) database.
How It Works
Frequently Asked Questions
What is a 510(k)?
A Premarket Notification 510(k) is a submission to FDA to demonstrate that a medical device is substantially equivalent to a legally marketed predicate device. FDA clearance via 510(k) is required for most Class II devices before U.S. distribution.
Which devices require a 510(k)?
Most Class II medical devices require 510(k) clearance. Some Class I devices also require 510(k) if FDA has not exempted them. Class III devices generally require PMA approval, not 510(k).
How long does 510(k) review take?
FDA’s performance goal is to complete 510(k) review within 90 days of acceptance. However, total time including preparation and any AI requests often extends to 6–12 months.
What is substantial equivalence?
Substantial equivalence means your device has the same intended use as a legally marketed predicate device and the same or different technological characteristics — but any differences do not raise new questions of safety and effectiveness.
Need Help with Your 510(k) Submission?
LMG supports medical device manufacturers through the complete 510(k) process — from predicate analysis to FDA clearance.
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