What Is a 510(k) Submission? A Complete 2025 Guide

A 510(k) submission is an FDA premarket notification proving that a new or modified Class II medical device is as safe and effective as a legally marketed predicate. The file must demonstrate substantial equivalence, contain full device description, labeling and test data, and—since 2024—is expected to follow the eSTAR template. Reviewers place submissions on hold if any section is incomplete.

Table of Contents

• Definition & regulatory basis
• Device classification & risk analysis
• Substantial equivalence & predicate strategy
• Required documents (Infographic)
• Common review holds & how to avoid them
• eSTAR template workflow
• FDA review timelines & recent trends
• How Redica benchmarks 510(k) readiness
• Frequently Asked Questions

Definition & regulatory basis (21 CFR 807)

The term “510(k)” comes from Section 510(k) of the FD&C Act and 21 CFR 807 Subpart E. A 510(k) submission notifies FDA of a manufacturer’s intent to market a Class II device and demonstrates substantial equivalence (SE) to a predicate device already cleared by FDA. Successful SE results in FDA clearance—not approval—to market the device in the United States.

Device classification & risk analysis

Before compiling a 510(k), confirm your device class:

• Class I (low risk) – often exempt from 510(k)
• Class II (moderate risk) – typical 510(k) pathway
• Class III (high risk) – Premarket Approval (PMA) required

Use FDA’s Product Classification Database, applicable guidance and ISO 14971 risk analysis to justify class and identify special controls.

Substantial equivalence & predicate strategy

The entire point of a 510(k) is to prove SE. Your submission should:

• Select one primary predicate (multiple predicates only in limited circumstances)
• Match intended use and technological characteristics—or justify differences
• Address each decision point in FDA’s SE flowchart (Evaluating Substantial Equivalence in Premarket Notification)

Required documents (Infographic)

Infographic placeholder – “The 510(k) Roadmap” timeline: tasks vs. weeks, decision points, Redica review-time heat-map.

• Cover letter & administrative info
• 510(k) summary or statement
• Detailed device description with photos/diagrams
• Indications for use & labeling (21 CFR 801)
• Comparison table to predicate device
• Performance testing: bench, biocompatibility, electrical safety, usability, clinical (if needed)
• Software & cybersecurity documentation (if applicable)
• Sterilization & shelf-life data
• eSTAR validation report

Common review holds & how to avoid them

Top “Refuse-to-Accept” (RTA) and Additional-Information (AI) triggers include:

• Missing predicate comparison table
• Incomplete test reports or acceptance criteria
• Out-of-date labeling or non-compliant UDI
• Software SOUP inventory gaps

For a line-by-line checklist, see Key document checklist for a complete 510(k) (anchor: full 510k submission guide).

eSTAR template workflow

The interactive eSTAR PDF guides sponsors through every 510(k) section, performs basic validation and reduces AI rounds. FDA strongly encourages—soon will require—eSTAR for most 510(k) submissions.

FDA review timelines & recent trends

Median FDA 510(k) review time dropped from 120 days in 2022 to 108 days in 2024, according to Redica clearance-memo analytics. The biggest drivers of delay:

• Poor biocompatibility justification (adds ≈25 days)
• Software cybersecurity questions (adds ≈18 days)

How Redica benchmarks 510(k) readiness

Need to benchmark your 510(k) readiness?
Redica hosts thousands of cleared 510(k) files, reviewer memos and AI letters—filterable by product code, reviewer or test type. Book a 15-minute walkthrough to see your gaps and speed up clearance.

Frequently Asked Questions

What is a 510(k) submission?
An FDA premarket notification proving a Class II device is substantially equivalent to a predicate device cleared for the same intended use.

What is substantial equivalence in a 510(k)?
Demonstrating that the new device has the same intended use and similar technological characteristics—or justified differences—when compared with a predicate.

How long does the FDA take to review a 510(k)?
Median review time is ~108 calendar days in 2024, assuming the file is complete and eSTAR is used.

What documents are needed for a 510(k) submission?
Cover letter, 510(k) summary, predicate comparison, labeling, full test data, risk analysis, sterilization info, eSTAR validation and more (see checklist link above).

What is the difference between a 510(k) and a PMA?
A 510(k) shows equivalence to a cleared device (Class II). A PMA is a comprehensive scientific review for high-risk Class III devices and requires clinical data.

When is a 510(k) submission not required?
For most Class I devices exempt under 21 CFR 862-892, for some very low-risk Class II devices with special controls, or when a modification does not affect safety or effectiveness.

Further reading: Key document checklist for a complete 510(k)