510(k) Clearance and Premarket Notification

What Is 510(k) Clearance?

A 510(k), also called a premarket notification, is a submission to FDA that shows a new medical device is substantially equivalent to a device already legally on the U.S. market. That existing device is known as the predicate. When FDA agrees, it issues a clearance letter and the device can be sold.

A 510(k) is required for most Class II devices and some Class I devices. It must be submitted at least 90 days before the device is marketed. The predicate can be a previously cleared device, a device reclassified from Class III, or a device that was legally marketed before May 28, 1976, when the Medical Device Amendments took effect.

A cleared device is not “FDA approved.” Approval applies to Class III devices through Premarket Approval (PMA). Using the wrong term in marketing is a common mistake that FDA treats as misleading.

What Substantial Equivalence Means

FDA finds a device substantially equivalent when, compared with the predicate, it:

• Has the same intended use, and
• Has the same technological characteristics, or
• Has different technological characteristics that do not raise different questions of safety and effectiveness, and performance data shows the device is as safe and effective as the predicate

Predicate selection drives the whole submission. A poorly chosen predicate can lead to extensive testing requests, a Not Substantially Equivalent (NSE) decision, or months of added review time.

Which FDA Pathway Fits Your Device?

What’s Included in Our 510(k) Services

• Device classification through review of FDA product codes and classification regulations
• Regulatory pathway strategy comparing exempt, 510(k), De Novo and PMA options
• Predicate device research and a side-by-side substantial equivalence comparison
• Pre-Submission (Q-Sub) meetings to get FDA feedback on testing plans before you spend on them
• Testing plan review for bench, biocompatibility, electrical safety, software and sterilization data
• eSTAR preparation and filing in FDA’s required electronic format
• Labeling and Indications for Use review so claims match what FDA will clear
• Additional Information (AI) responses to FDA deficiency letters within the required timeframe
• Post-clearance support for device changes, registration and listing, and marketing claim review

Core Service Areas

Device Classification and Pathway Strategy

FDA classifies devices into Class I, II or III based on risk. The correct classification regulation and product code determine whether you need a 510(k), qualify for an exemption, or need a De Novo or PMA. We confirm classification early so you do not build a submission around the wrong pathway.

Predicate Device Selection

We search FDA’s 510(k) database for predicates with matching intended use and similar technology, review each candidate’s clearance history and any recalls, and recommend the predicate that gives you the clearest route to substantial equivalence. Where helpful, we use a primary predicate supported by reference devices for specific features.

Pre-Submission Meetings

FDA’s Q-Submission program lets you ask questions about testing, predicates and study design before you file. FDA typically provides written feedback in about 70 days, with an optional meeting. We prepare the Pre-Sub package and questions, and help you apply FDA’s feedback to the final 510(k).

510(k) Preparation and eSTAR Submission

FDA requires most 510(k)s to be submitted electronically using the eSTAR template. After receipt, FDA conducts an initial technical screening, and a submission missing required elements can be placed on hold before substantive review begins. We draft the device description, substantial equivalence discussion, labeling, performance testing summaries, and required sections such as software documentation and cybersecurity for connected devices.

Responding to FDA Additional Information Requests

Most 510(k)s receive at least one Additional Information request. The review clock stops, and the company generally has 180 calendar days to respond in full or the submission is considered withdrawn. We analyze each deficiency, coordinate any new testing, and prepare a complete, organized response. If needed, we request a teleconference with the review team to clarify expectations.

Post-Clearance Changes and Compliance

A new 510(k) is required when a change could significantly affect safety or effectiveness, or represents a major change in intended use. We evaluate each change against FDA guidance and document the decision. We also help with establishment registration, device listing, and compliance with FDA’s Quality Management System Regulation, which aligns device quality requirements with ISO 13485 and took effect on February 2, 2026.

Our 510(k) Process

1. Discovery: we review your device, intended use, technology and target launch date
2. Pathway and predicate: we confirm classification and select the strongest predicate
3. Pre-Sub (optional): we get FDA feedback on testing and strategy when it reduces risk
4. Build and file: we prepare the eSTAR submission and file it with FDA
5. Review management: we handle screening, FDA questions and Additional Information responses
6. Clearance and beyond: we support registration, listing, labeling and future changes

Timelines depend on device complexity and testing status. We give you a realistic schedule at the start, including FDA review time.

Why Work With an FDA Attorney on Your 510(k)

Many device companies hire a regulatory consultant for their 510(k). An attorney brings the same technical submission work, plus protections a consultant cannot offer.

• Attorney-client privilege. Internal discussions about predicate risk, test failures and regulatory strategy are generally protected.
• Claims and labeling defense. We make sure your indications and marketing stay within what FDA cleared.
• Enforcement readiness. If FDA issues a Form 483, Warning Letter or questions a device change, your attorney already knows the file.
• Contract support. We review agreements with test labs, contract manufacturers and distributors that affect your regulatory position.

This page is for general informational purposes only and does not constitute legal advice or create an attorney-client relationship.